• PDR Search

    Required field
  • Advertisement
  • FDA Drug Updates

    FDA New Approvals

    Alere Determine HIV-1/2 Ag/Ab Combo Test

    The FDA has approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. Approved for use as an aid in the diagnosis of HIV-1 and HIV-2 infection, the Alere Determine HIV-1/2 Ag/Ab Combo test is also the first FDA-approved test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test. The test can be used by trained professionals in outreach settings to identify HIV-infected individuals who might not be able to be tested in traditional healthcare settings. The test does not distinguish between antibodies to HIV-1 and HIV-2, and is not intended to be used for screening of blood donors. Detection of HIV-1 antigen permits earlier detection of HIV-1 infection than is possible by testing for HIV-1 antibodies alone. The test can distinguish acute HIV-1 infection from established HIV-1 infection when the blood specimen is positive for HIV-1 p24 antigen but is negative for HIV-1 and HIV-2 antibodies. The Alere Determine HIV-1/2 Ag/Ab Combo test is manufactured by Orgenics, Ltd. (an Alere, Inc. company).
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm364480.htm


    Silvergate Pharmaceuticals Inc. has announced that the FDA approved Epaned (enalapril maleate powder for oral solution) to treat hypertension (high blood pressure) in people one month and older.
    For more information, visit: www.silvergatepharma.com/fda-approves-epaned-a-liquid-form-of-enalapril-for-children-and-adults/

    FluLaval Quadrivalent

    GlaxoSmithKline (GSK) has announced that the FDA has approved FluLaval Quadrivalent (influenza virus vaccine) for the active immunization of persons three years of age and older to help prevent disease caused by seasonal influenza virus subtypes A and B contained in the vaccine. GSK anticipates making a limited amount of FluLaval Quadrivalent available this influenza season.
    For more information, visit: http://us.gsk.com/html/media-news/pressreleases/2013/Additional-GlaxoSmithKline-quadrivalent-intramuscular-flu-vaccine-approved-by-FDA.html


    CSL Behring has announced that the FDA has approved a 10g (50mL) vial size for Hizentra, Immune Globulin Subcutaneous (human). The new vial size, 10g (50mL), will be available in the U.S. in October. In addition to the new 10g (50mL) vial, Hizentra is also available in 1g (5mL), 2g (10mL), and 4g (20mL) vials.
    For more information, visit: www.cslbehring.com/newsroom/Hizentra-10g-Vial-Size-Approved-by-FDA


    Galderma Laboratories, L.P. has announced that the FDA has approved Mirvaso (brimonidine) topical gel, 0.33% for the topical treatment of the facial erythema of rosacea in adults 18 years of age or older. Applied once daily, Mirvaso works quickly to reduce the redness of rosacea and lasts up to 12 hours. Galderma expects Mirvaso to be available in pharmacies September 2013.
    For more information, visit: www.galdermausa.com/NewsAndMedia/Galderma%20Receives%20FDA%20Approval%20of%20Mirvaso.pdf

    NovoPen Echo

    Novo Nordisk has announced that the FDA has granted clearance for the insulin device NovoPen Echo. This marks the first and only pen device in the U.S. with half-unit dosing and a memory function that records the dose and time passed since the last injection. This pen will be available to patients for use with NovoLog (insulin aspart [rDNA origin] injection) PenFill cartridges. Novo Nordisk plans to make NovoPen Echo available in the U.S. in early 2014.
    For more information, visit: http://press.novonordisk-us.com/2013-08-21-Novo-Nordisk-receives-U-S-FDA-clearance-for-the-insulin-injection-device-NovoPen-Echo


    The FDA has approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection. Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. It is a pill taken daily in combination with other antiretroviral drugs. Tivicay is approved for use in a broad population of HIV-infected patients. It can be used to treat HIV-infected adults who have never taken HIV therapy (treatment-naive) and HIV-infected adults who have previously taken HIV therapy (treatment-experienced), including those who have been treated with other integrase strand transfer inhibitors. Tivicay is also approved for children ages 12 years and older weighing at least 40kg who are treatment-naive or treatment-experienced but have not previously taken other integrase strand transfer inhibitors. Tivicay is marketed by ViiV Healthcare and manufactured by GlaxoSmithKline.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm364744.htm

    Trokendi XR

    Supernus Pharmaceuticals, Inc. has announced that Trokendi XR (topiramate) is now available to patients in the U.S. Trokendi XR is a novel once-daily extended release formulation of topiramate for the treatment of epilepsy.
    For more information, visit: http://files.shareholder.com/downloads/ABEA-5ZNGZM/2673463641x0x688920/2746d715-35b4-4b2f-a476-3ef0710fc708/SUPN_News_2013_9_5_General_Releases.pdf


    Ceptaris Therapeutics, Inc. announced that the FDA has granted marketing approval for the orphan drug Valchlor (mechlorethamine) gel for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. Valchlor is the first and only FDA-approved topical formulation of mechlorethamine, commonly known as nitrogen mustard. Valchlor is a gel that is applied topically once a day and dries on the skin.
    For more information, visit: www.ceptaris.com/news/2013AUG26.asp

    Vitek MS

    The FDA has allowed marketing in the U.S. of the first mass spectrometer system for automated identification of bacteria and yeasts that are known to cause serious illness in humans. The Vitek MS can identify 193 different microorganisms and can perform up to 192 different tests in a single automated series of testing, with each test taking about one minute. The Vitek MS can identify yeasts such as those from the Candida, Cryptococcus, and Malassezia groups, and bacteria from the Staphylococcaceae, Streptococcaceae, Enterobacteriaceae, Pseudomonadaceae, and Bacteroidaceae families, which are associated with skin infections, pneumonia, meningitis, and bloodstream infections. The Vitek MS is for clinical use for the identification of microorganisms cultured from human specimens. It is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections. The Vitek MS is manufactured by bioMerieux, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm365907.htm

    FDA New Indication


    The FDA has expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) to treat patients with late-stage (metastatic) pancreatic cancer. Abraxane is a chemotherapy drug that can slow the growth of certain tumors. Abraxane is intended to be used with gemcitabine, another chemotherapy drug, in patients with pancreatic cancer that has spread to other parts of the body. The FDA reviewed the new use for Abraxane under the agency’s priority review program, which provides for an expedited review of drugs. Abraxane was also granted orphan product designation for pancreatic cancer because it is intended to treat a rare disease or condition. Abraxane is also approved to treat breast cancer (2005) and non-small cell lung cancer (2012). It is marketed by Celgene.
    For more information, visit: www.fda.gov/newsevents/newsroom/pressannouncements/ucm367442.htm

    FDA Recalls

    Aidapak Services LLC, Select Repackaged Pharmaceuticals

    Aidapak Services LLC (Aidapak), is conducting a voluntary recall of specific unit dose repackaged products sent to 25 hospital inpatient pharmacies in the States of Washington, Oregon, California, and Arizona for products listed on the company’s website. Aidapak voluntarily recalled these products to the hospital/user level after learning of possible incorrect labeling which could involve OTC, prescription, and dietary supplement products. Some of the products, if incorrectly labeled, could result in patients receiving drugs that were not prescribed, which could result in allergic reactions or other undesired effects. Pregnant women could receive a drug that they should not take or, as a result of receiving an incorrect medication, patients may not receive proper treatment of their disease or condition. This may pose serious or life-threatening risk to a patient’s health. Aidapak shipped affected products to four states only: Washington, Oregon, California, and Arizona. Products affected by this recall are limited to strip packs packaged between May 1, 2013 and July 1, 2013, single-use dosage form, intended specifically to be administered to hospital patients while admitted to the hospital. All products affected by this recall are stamped with Aidapak’s packaging stamp.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm365417.htm

    Aminosyn II 10%, Sulfite-Free, 500mL

    Hospira, Inc. has announced that it is initiating a voluntary nationwide user-level recall of one lot of Aminosyn II 10%, Sulfite-Free, 500mL, NDC 0409-4164-03 Lot 26-138-JT. This action is due to one confirmed customer report where an unknown foreign particle was included in the injection port and in contact with product. The foreign particle was confirmed by Hospira as human hair. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. This recall is being conducted as a precautionary measure. The root cause has not been determined and is under investigation. Aminosyn II 10% is an amino acid injection used as a source of nitrogen in the nutritional support of patients where oral nutrition cannot be tolerated and is packaged in a 500mL flexible container, lot number 26-138-JT (the lot number may be followed by a 01) with an expiration date of August 1, 2014. The affected lot was distributed nationwide between March 2013 and August 2013 to wholesalers/distributors, hospitals, and pharmacies.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm366979.htm

    Avella Specialty Pharmacy Sterile Medications

    Avella Specialty Pharmacy is voluntarily recalling two compounded sterile medications, Bevacizumab 1.25mg/0.05mL PF and Vancomycin PF (BSS) 1%. The recall is a result of concerns of sterility assurance with the specialty pharmacy’s independent testing laboratory, Front Range Laboratories. To date, Avella has not received any reports of adverse events related to the recall. Avella was notified that in a recent inspection of Front Range Labs, FDA investigators observed methods used to assess sterility and other qualities (eg, strength and stability) which may have resulted in Avella receiving inaccurate laboratory test results on the specified lots. The FDA has raised concerns that test results obtained from Front Range Labs may not be reliable. Therefore, Avella decided to conduct this voluntary recall out of an abundance of caution. The recalled products were dispensed directly to healthcare providers nationwide and the medications can be identified based on product label and corresponding medication name and lot number.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm367719.htm

    Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution

    Altaire Pharmaceuticals, Inc. has announced that it is voluntarily recalling a total of nine lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30mL, to the consumer level. There have been no reports of adverse effects to consumers so far. However, due to complaints of mold found in the 30mL bottles after use, concerns regarding the effectiveness of the preservative after use and handling of the product by consumers have prompted the recall. It has been confirmed by Altaire that all lots of product were sterile at the time of release, and that the preservative was effective when challenged against the USP Preservative Effectiveness Test. It has also been confirmed by Altaire that its production facility is not the source of any reported contaminants. The product is known generically as Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution and labeled as follows: equate Restore Tears Lubricant Eye Drops Carboxymethylcellulose Sodium 0.5%, Sterile, 1 fl. oz. (30mL) - Distributed by Wal-Mart Stores, Inc.; Lubricant Eye Drops For Mild To Moderate Dry Eye, Sterile, 1 fl. oz. (30mL), for Mild to Moderate Dry Eye - Distributed by CVS Pharmacy, Inc.; and lubricant eye drops for mild to moderate dry eye, Sterile, 1 fl. oz. (30mL) - Dist. by Target Corp. The lots were distributed between February 2012 and April 2013. The product was sold nationwide at retail stores. Altaire Pharmaceuticals is initiating the recall as a precautionary measure. Altaire Pharmaceuticals is notifying its customers of the recall by phone and letters for further notification to their retail stores.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm367559.htm

    Concentrated Motrin Infants Drops Original Berry Flavor

    McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. (McNeil) is voluntarily recalling at the retail level three lots, approximately 200,000 bottles, of Concentrated Motrin Infants’ Drops Original Berry Flavor 1/2 fl. oz. bottles distributed in the U.S. This recall is being conducted with the knowledge of the FDA. McNeil is asking retailers to remove the affected lots from store shelves, and is asking consumers to stop using and dispose of any product they may have that is included in this recall. After releasing these three lots of Concentrated Motrin Infants’ Drops Original Berry Flavor 1/2 fl. oz. into the market, tiny plastic particles (approximately 1mm in size or about the size of a poppy seed) were identified in a different product lot during manufacturing. This lot was not released to the market. It was determined that the particles originated in a shipment from a third party supplier of ibuprofen, the active ingredient in Concentrated Motrin Infants’ Drops Original Berry Flavor 1/2 fl. oz. Out of an abundance of caution, McNeil is voluntarily recalling the three lots released to the market made with the same batch of active ingredient. McNeil has worked with the third party to ensure that corrective measures are currently in place and are effective. The potential for adverse medical events related to the reason for this recall is not likely. Concentrated Infants’ Motrin Drops Dye-Free Berry Flavor 1 fl. oz. is not included in this recall. Children’s or Adult Motrin products are not included in this recall.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm367550.htm


    Cubist Pharmaceuticals, Inc. has announced it is voluntarily recalling four lots of Cubicin (daptomycin for injection) to the user level due to the presence of particulate matter found in a number of vials from certain lots. No adverse events have been reported to date in association with a product complaint of vials containing glass particulates. Cubist is notifying customers by letter and phone.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm366753.htm

    Hospira Blood Sets

    Hospira, Inc. has announced a recall of certain blood sets. There have been reports from customers of instances in which the outer wall of blood bags were punctured with the piercing pin on certain Hospira blood sets during insertion of the pin into the blood bag. If the piercing pin on this product punctures the outer wall of a blood bag, it may result in spillage of the blood and blood products stored in the bag, resulting in a delay/interruption in therapy. Delay/interruption in therapy can potentially lead to significant injury or death. This issue has been identified as a contributing factor in one report of a patient death due to a delay/interruption in therapy. The impacted list numbers are: 14200-04-28 Secondary Blood Set; 14203-04-28 Blood Set; 14206-04-28 Y-type Blood Set; 14207-04-28 Blood Set; 14210-04-28 Plum™ Blood Set; 14211-04-28 Plum Blood Set; 14212-04-28 Plum y-type Blood Set, 14217-04-28 y-type Blood Set and 14219-04-28 Y-type Blood Set. These sets were distributed July 2011 through February 2013. The root cause of the punctures has been identified as the design of the new International Organization for Standardization (ISO)-compliant pin, which has a sharp point that can sometimes pierce the wall of non-ISO-compliant blood bags. At this time, there is no need for customers to discontinue use of or return Hospira blood sets. However, Hospira recommends users exercise extreme caution when piercing blood bags with a Hospira blood set mentioned and make sure that all instructions for use included with the blood bag and facility’s protocol for spiking blood bags are completely followed in order to minimize the possibility of puncturing the outer wall of the blood bag. Hospira has begun distribution of sets with a blunter piercing pin that is shorter than the pins in the Impacted List Numbers that came available in March 2013.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm364973.htm

    JCB Laboratories Products

    JCB Laboratories (JCB) is issuing a recall of six lots of sterile drug products to the user level due to concerns of sterility assurance following a recent inspection by FDA of Front Range Laboratories of Loveland, Colorado, one of the contract testing labs used by JCB. The following JCB compounded products are subject to the recall: Sodium thiosulfate, 25% (250mg/mL), Sodium citrate, 4% solution for injection, Sodium citrate, 4% with gentamicin 320mcg/mL solution for injection, and Acetylcysteine, 20% solution for inhalation. The recalled products were distributed to outpatient dialysis clinics in multiple states from July 8, 2013, through August 20, 2013. JCB has not received any reports of adverse events related to this recall to date. In the recent inspection of Front Range Labs, the FDA stated it observed that methods used by Front Range to assess sterility and other qualities (eg, strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm366503.htm

    Medaus Pharmacy Sterile Compounded Products

    Medaus Pharmacy is voluntarily recalling certain sterile compounded consumer products due to inability to confirm that the quality control testing performed on these specific lots by an independent, third party laboratory was conducted in a manner consistent with standards. Medaus has not received any reports of adverse events related to the products affected by this recall to date. Medaus is notifying its customers by telephone and email, and is arranging for return of affected products.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm367421.htm

    Methylcobalamin 5mg/mL 30mL & Multitrace-5 Concentrate 10mL

    Park Pharmacy & Compounding Center is voluntarily recalling two lots of products Methylcobalamin 5mg/mL 30mL Amber Vials Lot #06132013@1 Exp: 12/10/2013 and Multitrace-5 Concentrate 10mL Amber Vials Lot #05212013@20 Exp: 11/17/2013 for injection, to the consumer level. In a recent inspection, FDA investigators observed that methods used by the laboratory to assess sterility might have resulted in pharmacies receiving inaccurate laboratory test results. The FDA has concerns that results obtained from the laboratory are not reliable. The prescription preparations were sold during June and July of 2013, in the following states: California, Florida, New Mexico, and Indiana. The products would have been sold directly to customers (pick up and by mail) and to physician offices by prescription (pick up and by mail). To date there have been no reported adverse events associated with the use of these products and there has been no confirmation of lack of sterility of these products. Park Pharmacy & Compounding Center is notifying its customers by phone and mail and is arranging for return of all recalled product lots. Customers that have product that is being recalled should stop using it and contact Park Compounding to arrange for return of unused product.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm366348.htm

    Monoject Prefill Flush Syringes

    Covidien has announced that it has initiated a voluntary recall of certain lots of Monoject prefill flush syringes. This recall is being conducted due to the risk that a number of the syringes were filled with water but not subjected to the autoclave sterilization process. These products are labeled as either sodium chloride flush or heparin lock flush. Some of these syringes have the mismatched syringe tip cap, syringe label, filled volume, and wrapper. However, for the sodium chloride flush syringes with matched tip cap, syringe label, filled volume, and wrapper, there are no visual cues for the clinician to identify the problematic products. If non-sterile fluid is administered, there is a health risk of life-threatening infection to the blood stream or other areas. In addition, if the clinician uses the heparin lock flush syringe containing only water on peripheral or venous catheters, the patency of the intravascular device may not be maintained and clotting may occur. This could result in non-functional intravenous access requiring the device to be replaced.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm365719.htm

    MRidium 3860+ Infusion Systems Equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit

    The FDA has notified healthcare professionals of a Class I recall of the Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit. The DERS can potentially give an incorrect recommended value for the pump infusion rate during the initial infusion setup. This is due to a specific key sequence when the override feature of the DERS drug limits is activated. A device malfunction can result in an increased risk of over-infusion or under-infusion if the infusion is started with this rate value. This can cause serious adverse health consequences, including death. These products were manufactured from October 1, 2011 through June 27, 2013 and distributed from October 6, 2011 through June 28, 2013. Iradimed Corporation notified its customers by phone and on July 1, 2013, they sent an URGENT MEDICAL DEVICE RECALL NOTICE to all customers. The notice described the product, problem, and actions to be taken. Customers were instructed to identify the MRidium 3860+ Infusion Pumps that have the 1145 DERS Library card (AM05) installed. If these are not installed, no further action is required at this time. However, if the DERS Library card is installed, customers should remove the 1145 DERS Library Card from the 3860 Pump using the instructions provided in the URGENT MEDICAL DEVICE RECALL NOTICE. The product will be repaired (reconditioned) by installing a software upgrade that corrects this problem. The updated software (version 3.5.1) can be seen during the 3860+ Pump's power on cycle.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm364667.htm

    Specialty Compounding Sterile Products

    Specialty Compounding, LLC is voluntarily recalling all lots of sterile medications within expiry. The recall was initiated after reports of bacterial infection affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area, whose treatment included IV infusions of calcium gluconate from Specialty Compounding. There is a potential association between the infections and the medication at this time. No calcium gluconate was shipped outside of Texas. If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. Recalled products were distributed directly to hospitals and physician offices in Texas. Recalled products were also sent directly to patients located nationwide with the exception of North Carolina. Specialty Compounding is notifying its customers by telephone, fax, email, and/or regular mail of this recall. Users or recipients of these products should immediately discontinue use and return the recalled unexpired products to Specialty Compounding.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm365315.htm

    Wellness Pharmacy Products

    Wellness Pharmacy, Inc. has issued a nationwide voluntary recall of certain sterile products due to laboratory results indicating microbial contamination. To date, Wellness Pharmacy has not received any reports of adverse events related to this recall. This recall was initiated after Wellness Pharmacy was notified that in a recent inspection of Front Range Labs, FDA investigators observed methods used by Front Range Labs to assess sterility and other qualities (eg, strength and stability) may have resulted in Wellness Pharmacy receiving inaccurate sterility test results on following products: Dexpanthenol 250mg/mL, Magnesium Sulfate 50%, Methylcobalamin 1mg/mL, Sodium Phenylbutyrate 200mg/mL, R.L. Glutathione 100mg/mL, and Ascorbic Acid (cassava) 500mg/mL. Recalled medications were distributed to individual patients and to physician offices nationwide. These liquid medications are in either clear or amber sterile vials ranging in size from 1mL to 50mL. The medications can be identified by the label on each vial, which will have the name of the drug, strength or concentration, lot number, use by date, and vial size.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm366505.htm

    FDA Alerts


    The FDA has required that the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent. The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection. Approved fluoroquinolone drugs include Levaquin (levofloxacin), Cipro (ciprofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), Floxin (ofloxacin), and Factive (gemifloxacin). The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk. The FDA will continue to evaluate the safety of drugs in the fluoroquinolone class and will communicate with the public again if additional information becomes available.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm365050.htm


    The FDA is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking the drug Gilenya (fingolimod). This is the first case of this disease, called progressive multifocal leukoencephalopathy (PML), reported following the administration of Gilenya to a patient who had not previously received Tysabri (natalizumab), an MS drug associated with a higher risk of PML. Patients should not stop taking Gilenya without first discussing any questions or concerns with their healthcare professionals. The FDA is providing this alert while they continue to investigate the PML case, and they are working with Gilenya’s manufacturer, Novartis, to obtain and review all available information about this occurrence. The FDA will communicate their final conclusions and recommendations after their evaluation is complete. Gilenya is used to treat relapsing forms of MS. The drug was approved for use in the U.S. in September 2010. Novartis reports that approximately 71,000 patients worldwide have been treated with Gilenya. The patient who developed PML received nearly eight months of Gilenya treatment before being diagnosed with PML. The patient had been treated with interferon beta-1a and azathioprine for one month before initiating Gilenya treatment; those medications were stopped when Gilenya was started. The patient also received multiple courses of intravenous corticosteroids for several months before and during Gilenya treatment. The diagnosis was made based on clinical symptoms and the detection of JC viral DNA in the cerebrospinal fluid. Gilenya treatment was stopped.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm366529.htm

    NuVision Pharmacy Sterile Products

    The FDA is reminding healthcare providers about safety concerns with all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. Healthcare providers should not administer any NuVision Pharmacy sterile products to patients because the products’ sterility is not assured. This alert follows the FDA’s notice on May 18, 2013 recommending that healthcare providers and other healthcare professionals, including hospital staff, immediately check their medical supplies for NuVision Pharmacy sterile products, quarantine those products, and not administer them to patients. NuVision Pharmacy has repeatedly declined to recall its sterile products. The FDA most recently issued a letter to NuVision on July 26, 2013, requesting an immediate recall of all lots of sterile products that have not passed their expiration dates produced at NuVision. In the letter, the FDA outlined poor sterile production practices observed by FDA investigators during an April 2013 inspection of NuVision’s Dallas facility. The FDA explained that those practices raised concerns about a lack of sterility assurance of NuVision’s sterile drug products. The FDA noted that if a drug product marketed as sterile contains microbial contamination, patients could be at risk for serious, potentially life-threatening infections. NuVision responded to the letter by refusing to recall its sterile products. Under its authority, the FDA cannot require NuVision to undertake such a recall. Therefore, the agency reminds healthcare providers not to use any sterile products from NuVision. In April 2013, NuVision recalled methylcobalamin injection and lyophilized injection products due to a lack of sterility assurance and concerns associated with the quality control processes identified during the FDA’s April 2013 inspection. The FDA received adverse event reports of fever, flu-like symptoms, and soreness at the injection site associated with the methylcobalamin injection product that was previously recalled. The agency is not aware of any adverse event reports associated with other sterile products from NuVision.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm365402.htm