FDA New Approvals
2015/16 Formulation of Flublok
Protein Sciences Corporation announced that the FDA has approved the composition of Flublok influenza vaccine for the 2015/16 flu season. Every year, influenza vaccine manufacturers must receive approval from the FDA for changes they make to their vaccines so that the vaccines protect against the new strains of flu that are predicted to circulate next flu season. This approval enables Flublok to be delivered to distributors and retailers in mid-August.
Learn more about the 2015/16 Formulation of Flublok
Bio-Rad BioPlex 2200 HIV Ag-Ab Assay
The FDA approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay, the first FDA-approved diagnostic that differentiates between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens.
Learn more about the Bio-Rad BioPlex 2200 HIV Ag-Ab Assay
Bristol-Myers Squibb Company announced that Daklinza (daclatasvir), an NS5A replication complex inhibitor, has been approved by the FDA. Daklinza is indicated for use with sofosbuvir for the treatment of patients with chronic hepatitis C virus genotype 3 infection.
Learn more about Daklinza
Veloxis Pharmaceuticals announced the FDA approval of Envarsus XR
(tacrolimus extended-release tablets) for the prophylaxis of rejection in
kidney transplant patients who require or desire conversion from other
twice-daily tacrolimus products to once-daily Envarsus XR. Veloxis expects
Envarsus XR to be available to patients in the US and their physicians in
Learn more about Envarsus XR
Galderma Laboratories, L.P. announced that the FDA approved
antibiotic-free Epiduo Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5%,
for the once-daily, topical treatment of acne vulgaris. Epiduo Forte Gel will
be available by prescription in early September 2015.
Learn more about Epiduo Forte
Bayer HealthCare announced that the FDA has approved Finacea (azelaic acid) Foam, 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Finacea Foam will be available in the US by prescription only, beginning in September 2015.
Learn more about Finacea Foam
AstraZeneca announced that
the FDA has approved Iressa (gefitinib)
tablets, 250mg once daily, for the first-line treatment of patients with
metastatic non-small cell lung cancer whose tumors have epidermal growth factor
receptor exon 19 deletions or exon 21 (L858R) substitution mutations, as
detected by an FDA-approved test.
Learn more about Iressa
Novartis announced the FDA
has approved Odomzo (sonidegib, formerly LDE225) 200mg capsules for the
treatment of adult patients with locally advanced basal cell carcinoma that has
recurred following surgery or radiation therapy, or those who are not
candidates for surgery or radiation therapy.
Learn more about Odomzo
Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Device
The FDA authorized use of
the first prosthesis marketed in the US for adults who have amputations above
the knee and who have rehabilitation problems with, or cannot use, a
conventional socket prosthesis. The OPRA device instead uses fixtures and
screws implanted into the patient’s remaining thighbone to connect an external
Learn more about the OPRA device
Sanofi and Regeneron Pharmaceuticals, Inc. announced that the FDA approved Praluent (alirocumab) Injection, the first FDA-approved treatment in a new class of drugs known as proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of low-density lipoprotein cholesterol.
Learn more about Praluent
Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck announced that the FDA approved Rexulti (brexpiprazole) as an adjunctive therapy for the treatment of adults with major depressive disorder and as a treatment for adults with schizophrenia. Rexulti is expected to become available to patients in the US in early August 2015.
Learn more about Rexulti
Aprecia Pharmaceuticals Company announced that the FDA has approved Spritam (levetiracetam) for oral use as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in adults and children with epilepsy. Spritam utilizes Aprecia’s proprietary Zip Dose Technology platform, a groundbreaking advance that uses three-dimensional printing to produce a porous formulation that rapidly disintegrates with a sip of liquid.
Learn more about Spritam
AbbVie announced that the FDA approved Technivie (ombitasvir, paritaprevir, and ritonavir tablets) in combination with ribavirin for the treatment of adults with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection who do not have cirrhosis. Technivie is an all-oral, interferon-free, direct-acting antiviral treatment approved in the US for adult patients with GT4 chronic HCV infection.
Learn more about Technivie
FDA First-Time Generic Approvals
Hospira, Inc. has announced it had obtained FDA approval for the launch of bivalirudin for injection, a generic version of The Medicines Company's Angiomax.
Learn more about generic Angiomax
FDA New Indications
Ipsen announced that the FDA has approved its supplemental Biologics License Application for Dysport (abobotulinumtoxinA) for the treatment of upper limb spasticity in adult patients after the submission of the dossier in September 2014. Dysport is now approved for the treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors, wrist flexors, and finger flexors.
Learn more about Dysport
Amgen announced that the FDA approved the supplemental New Drug Application for Kyprolis (carfilzomib) for Injection in combination with Revlimid (lenalidomide) and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy. Kyprolis is also indicated under FDA accelerated approval as a single agent for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Learn more about Kyprolis
0.9% Sodium Chloride Injection, USP, 50mL and 100mL
Baxter International Inc. announced it is voluntarily recalling two lots of intravenous solutions to the hospital/user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. The matter was identified prior to patient administration and there have been no adverse events associated with this issue reported to Baxter. This recall affects Lot Numbers P319921 and P327635. The lots being recalled were distributed to customers and distributors in the US between October 7, 2014 and July 14, 2015.
Learn more about 0.9% Sodium Chloride Injection, USP, 50mL and 100mL
0.9% Sodium Chloride Injection
Baxter International Inc. announced it is voluntarily recalling one lot of intravenous solution to the hospital/user level due to the potential for leaking containers, particulate matter, and missing port protectors. This recall affects Lot Number C964601. The lot being recalled was distributed to customers and distributors nationwide between January 22, 2015 and February 12, 2015.
Learn more about 0.9% Sodium Chloride Injection
Adrucil 5g/100mL (50mg/mL)
Teva Parenteral Medicines announced a voluntary recall of six lots of Adrucil (fluorouracil injection, USP) 5g/100mL (50mg/mL) due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life threatening if vital organs are affected. To date, Teva has not received any reports of adverse events related to this recall.
Learn more about Adrucil 5g/100mL (50mg/mL)
Akttive High Performance Fat Burner Gold Capsules
Life & More, L.L.C. is voluntarily
recalling 783 Bottles from Lot #000185004400 Akttive High Performance Fat Burner Gold capsules weight loss supplements. The firm was informed by the FDA
that a sample of Akttive High
Performance Fat Burner Gold capsules
was found to contain sibutramine, desmethylsibutramine, and phenolphthalein.
The products were distributed from January 2012 until July 2015.
Learn more about Akttive High Performance Fat Burner Gold Capsules
Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one lot of hydrochlorothiazide
tablets 25mg 1000-count bottle to the consumer level. This recall has been
initiated as a precautionary measure due to the identification of a Clopidogrel
tablet found in a bottle of the product. The affected hydrochlorothiazide
tablets include Lot # GHYL15028 - Expiration April 2018, and were distributed
nationwide directly to wholesalers, retailers, and pharmacies May 21–28, 2015.
Learn more about Hydrochlorothiazide Tablets
Sterile Human and Veterinary Compounded Drugs
Moses Lake Professional Pharmacy is voluntarily recalling human and veterinary sterile compounded drugs that are unexpired to the consumer level due to lack of sterility assurance. The company has not received any reports of product contamination or adverse events to date, and is issuing this voluntary recall out of an abundance of caution following a recent inspection which identified an issue with sterility assurance. The recalled products were made from 7/21/2014 through 7/21/2015, and dispensed to patients or distributed to physicians for further administering to patients in the states of Arizona, Idaho, Florida, Oregon, Texas, and Washington.
Learn more about Sterile Human and Veterinary Compounded Drugs
Brintellix (vortioxetine) and Brilinta (ticagrelor)
FDA is warning healthcare professionals and patients that reports of confusion between the antidepressant Brintellix and anti-blood clotting medication Brilinta have resulted in the wrong medication being prescribed or dispensed. The FDA determined that the main reason for the confusion between these two medications is the similarity of their brand (proprietary) names. None of the reports indicates that a patient ingested the wrong medication; however, reports of prescribing and dispensing errors continue.
Learn more about Brintellix and Brilinta
Calcium Chloride Intravenous Infusion 10% w/v
In April 2015, Mylan Institutional conducted a voluntary market withdrawal of 14 lots of Calcium Chloride Intravenous Infusion 10% w/v, packaged in 10mL prefilled syringes. In June 2015, Mylan Institutional issued a second notification of the market withdrawal. The FDA has recently become aware that some units of this drug may still be on the market.
Learn more about Calcium Chloride Intravenous Infusion 10% w/v
The FDA is providing a detailed list of supplemental duodenoscope
reprocessing measures that emerged from an agency-led expert panel meeting
earlier this year. Hospitals and healthcare facilities that utilize
duodenoscopes can, in addition to meticulously following manufacturer
reprocessing instructions, take one or more of these additional steps to further
reduce the risk of infection and increase the safety of these medical devices.
Learn more about Duodenoscope Reprocessing
Gadolinium-based Contrast Agents
The FDA is investigating the risk of brain deposits following repeated
use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging
(MRI). Recent publications in the medical literature have reported that
deposits of GBCAs remain in the brains of some patients who undergo four or
more contrast MRI scans, long after the last administration. It is unknown
whether these gadolinium deposits are harmful or can lead to adverse health
Learn more about Gadolinium-based Contrast Agents
The FDA is warning that a case of definite progressive multifocal
leukoencephalopathy (PML) and a case of probable PML have been reported in
patients taking Gilenya (fingolimod) for multiple sclerosis (MS). These are the
first cases of PML reported in patients taking Gilenya who had not been
previously treated with an immunosuppressant drug for MS or any other medical
condition. As a result, information about these recent cases is being added to
the drug label.
Learn more about Gilenya
Implantable Left Ventricular Assist Devices (LVADs)
The FDA is alerting healthcare providers, patients, and caregivers about
serious adverse events associated with LVADs. These adverse events include an
increased rate of pump thrombosis (blood clots inside the pump) with Thoratec’s
HeartMate II and a high rate of stroke with the HeartWare HVAD since approval
of the devices. The FDA is also aware of bleeding complications related to both
the Thoratec HeartMate II and HeartWare HVAD.
Learn more about Implantable LVADs
Lariat Suture Delivery Device
The FDA is alerting healthcare providers and patients of reports of
patient deaths and other serious adverse events associated with the use of the
Lariat Suture Delivery Device and its associated devices to close the left
atrial appendage, a pouch-like region of the left atrium in the heart, in
patients with irregular heart rhythm (atrial fibrillation) to prevent stroke.
Learn more about Lariat Suture Delivery Device
Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
The FDA is strengthening an existing label warning that non-aspirin NSAIDs increase the chance of a heart attack or stroke. Based on the FDA’s comprehensive review of new safety information, the FDA is requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. The FDA will also request updates to the OTC non-aspirin NSAID Drug Facts labels.
Learn more about Non-aspirin NSAIDs
The FDA is warning that a serious lung condition called pulmonary hypertension, which is high pressure in the blood vessels leading to the lungs, has been reported in infants and newborns treated with Proglycem (diazoxide) for low blood sugar. In all cases, the pulmonary hypertension resolved or improved after Proglycem was stopped. The FDA is continuing to investigate this safety issue and will determine whether changes are needed in the Proglycem prescribing information.
Learn more about Proglycem
Symbiq Infusion System
The FDA, the US Department of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team, and Hospira are aware of cybersecurity vulnerabilities associated with the Symbiq Infusion System. The FDA strongly encourages healthcare facilities transition to alternative infusion systems, and discontinue use of these pumps. Hospira and an independent researcher confirmed that Hospira’s Symbiq Infusion System could be accessed remotely through a hospital’s network. This could allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies.
Learn more about the Symbiq Infusion System