FDA New Approvals
Avion Pharmaceuticals received approval of its new drug application for the oral contraceptive Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets). Avion expects to commercially launch this new oral contraceptive to the prescribing community in the spring of 2018. Balcoltra is the only branded oral contraceptive combining 0.1mg levonorgestrel, 20mcg ethinyl estradiol tablets, and ferrous bisglycinate tablets 36.5mg.
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The FDA approved Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for ≥3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.
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The FDA has approved a new drug application for Dexycu (dexamethasone intraocular suspension), a dropless, long-acting therapeutic for treating inflammation associated with cataract surgery.
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Erleada (apalutamide) has been approved for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer. Erleada works by blocking the effect of androgens, a type of hormone, on the tumor. These androgens, such as testosterone, can promote tumor growth.
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The FDA has approved Firvanq (vancomycin HCl)
oral solution for the treatment of Clostridium difficile-associated diarrhea (CDAD) and enterocolitis
caused by Staphylococcus aureus, including
methicillin-resistant strains. Firvanq is
the only FDA-approved vancomycin oral liquid treatment option for CDAD-associated
diarrhea. Firvanq will be available in
25mg/mL and 50mg/mL strengths and will replace CutisPharma's First-Vancomycin
unit-of-use compounding kit.
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The FDA has approved Lutathera (lutetium Lu 177 dotatate) for use in the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Lutathera is a peptide receptor radionuclide therapy and a first in its class drug. The drug is approved for use in adult patients with somatostatin receptor-positive GEP-NETs and acts by binding to the somatostatin receptor and then entering the tumor cell, allowing radiation to damage the tumor cells.
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The FDA recently approved Symfi Lo, which is a fixed-dose combination product containing 400mg efavirenz, 300mg lamivudine and 300mg tenofovir disoproxil fumarate (equivalent to 245mg of tenofovir disoproxil) and is indicated as a complete regimen for the treatment of HIV-1 in adult and pediatric patients weighing at least 35kg.
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FDA has approved Symdeko (tezacaftor/ivacaftor
and ivacaftor) to treat cystic fibrosis in people ages 12 years and older who have two copies of the F508del
mutation or one mutation that is responsive to Symdeko.
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The FDA has approved Trulance (plecanatide) for the treatment of chronic idiopathic constipation in adult patients. Trulance, taken orally once daily, works locally in the upper GI tract to stimulate secretion of intestinal fluid and support regular bowel function.
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FDA First-Time Generic Approvals
Remifentanil HCl Injection
This new generic for Ultiva is indicated for IV administration as an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures; for continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting, and as an analgesic component of monitored anesthesia care in adult patients.
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FDA New Dose Strengths
Sandoz, a Novartis division, announced FDA approval of Glatopa (glatiramer acetate injection) 40mg/mL. Glatopa 40mg/mL is FDA-approved as a fully-substitutable, AP-rated generic version of Copaxone (glatiramer acetate injection) 40mg/mL three-times-a-week therapy for relapsing forms of multiple sclerosis. Glatopa 40mg/mL is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Glatopa 40mg/mL, along with Glatopa 20mg/mL, will offer patients a complete range of dosing options. Glatopa 20mg/mL was made available in the US in June 2015. Patients can expect the same patient services for Glatopa 40mg/mL as for Glatopa 20mg/mL.
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FDA New Dosing
AstraZeneca announced the FDA approved Daliresp (roflumilast) 250mcg as a starting dose once daily for the first 4 weeks of treatment followed by 500mcg thereafter to help reduce the rate of treatment discontinuation in some patients. Daliresp is currently indicated for reducing the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
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FDA New Indications
The FDA has approved the use of Avycaz (ceftazidime and avibactam) to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age or older. This is the first gram-negative antibiotic approved in the US to treat HABP/VABP in over 15 years.
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The FDA has approved a supplemental new drug application for the anemia drug Feraheme (ferumoxytol) injection beyond the current chronic kidney disease indication to include all eligible adults with iron deficiency anemia who cannot tolerate or have failed to respond adequately to oral iron.
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Boehringer Ingelheim announced that the FDA has approved a supplemental new drug application for Gilotrif (afatinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. The new label includes data on three additional EGFR mutations: L861Q, G719X, and S768I. Gilotrif, an oral, once-daily tablet, was previously approved in the US for the first-line treatment of patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations. In addition, Gilotrif is approved in the US for patients with squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.
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The FDA approved Zytiga (abiraterone acetate) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer. The FDA initially approved Zytiga with prednisone in 2011 for patients with metastatic castration-resistant prostate cancer (CRPC) who had received prior chemotherapy and expanded the indication in 2012 for patients with metastatic CRPC.
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Apace Packaging LLC Acyclovir Tablets
Apace Packaging LLC is voluntarily recalling one lot of acyclovir tablets, USP, 400mg, 50ct unit dose, NDC# 50268-061-15, lot number 19900, to the retail level. These products have been recalled due to a product mix-up. A small number of blister cards containing acyclovir tablets, 400mg, UD blister cards may potentially also include torsemide, 20mg tablets.
Learn more about the Apace Packaging LLC acyclovir tablets recall
Arthri-D, LLC Arthri-D
Arthri-D, LLC is
recalling its dietary supplement “Arthri-D 120ct” Lot#1701-092 because
it may be contaminated with Salmonella. The product was distributed nationwide through mail
orders. It comes in a 225 cc, white plastic HDPE bottle marked with lot
#1701-092 on the label and with a manufacturing date of March 2017 stamped on
Learn more about the Arthri-D, LLC Arthri-D recall
AuroMedics Pharma LLC Levofloxacin Injection
AuroMedics Pharma LLC is voluntarily recalling one lot of Levofloxacin in 5% dextrose injection 250mg/50mL in a single-use flexible container NDC 55150-243-46, Lot CLF160003, Expiry date May 2018, to the hospital level. The product has been found to contain visible particulate matter tentatively identified as mold. This problem was discovered as a result of a product complaint in which the contents of one flexible bag was found to contain white particulate matter.
Learn more about the AuroMedics Pharma LLC levofloxacin injection recall
Baxter International Inc. Nexterone
Baxter International Inc. is expanding its November 10, 2017 recall to include a second lot (NC109123) of Nexterone (amiodarone HCl) 150mg/100mL premixed injection, due to the potential presence of particulate matter. The affected lots were distributed between 7/21/2017 and 10/2/2017 in the US to wholesalers/distributors and healthcare facilities.
Learn more about the Baxter International Inc. Nexterone recall
Break Ventures/California Basics Zero for Him
Break Ventures/California Basics is recalling its dietary supplement “Zero for
Him 150ct” Lot#1710-638 because it may be
contaminated with Salmonella. The product was distributed nationwide through Amazon.
It comes in a 400cc, light amber PETE bottle marked with lot #1710-638 on the
bottom and with an expiration date of November 2020 stamped on the side.
Learn more about the Break Ventures/California Basics Zero for Him recall
Flawless Beauty, LLC Unapproved Drugs
Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the FDA to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. View the recall notice for a complete list of affected products. All glutathione products were sold in multi-vial whitening kits, either alone or in combination with ampules of vitamin C and sterile water. Vials or ampules of vitamin C or sterile water purchased separately or as part of these whitening kits are also recalled.
Learn more about the Flawless Beauty, LLC unapproved drugs recall
Kareway Products, Inc Gericare Eye Wash
Kareway Products, Inc is voluntarily recalling 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fl. oz. to the hospital, retail, or consumer level. The product has been found to have potential microbial contamination which compromises sterility. It is packaged in 4 fl. oz. (118mL) bottles. The affected Gericare Eye Wash, Sterile Eye Irrigation Solution lot includes the following Lot# 86041601 and expiration date of 09/2019. The product can be identified by UPC 3-57896-18604-3.
Learn more about the Kareway Products, Inc Gericare Eye Wash recall
Magno-Humphries Laboratories, Inc. Basic Drugs Brand Senna Laxative Tablets
Magno-Humphries Laboratories, Inc. is voluntarily recalling one lot of Basic Drugs Brand of Senna Laxative tablets, 8.6mg sennosides to the consumer level due to a customer complaint that their bottle labeled as Senna Laxative actually contained Basic Drugs Brand of naproxen sodium 220mg.
Learn more about the Magno-Humphries Laboratories, Inc. Basic Drugs Brand Senna Laxative tablets recall
PharMEDium Services, LLC Sterile Products (Expanded)
PharMEDium Services, LLC is voluntarily expanding the recall issued in December 2017 to include additional lots of sterile drug products including potassium chloride, glycopyrrolate, fentanyl citrate, morphine sulfate, hydromorphone HCl, midazolam HCl, succinylcholine chloride, bupivacaine HCl, ropivacaine HCl, labetalol HCl, adenosine, and ephedrine. The expanded recall includes all lots within expiry compounded at the Memphis, TN facility. Finished product release testing for both sterility and endotoxin were acceptable for all lots. Although there were no defects identified in these products, as a conservative measure, this recall is being expanded.
Learn more about the PharMEDium Services, LLC sterile products expanded recall
Primus Pharmaceuticals, Inc. Limbrel Products
Primus Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at the FDA's request. The FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel. Between January 1, 2007 and November 9, 2017, the FDA received 30 adverse event reports of elevated liver function tests or acute hypersensitivity pneumonitis associated with the use of Limbrel products.
Learn more about the Primus Pharmaceuticals, Inc. Limbrel products recall
Becton-Dickinson Syringes Rubber Stoppers Replacement
Becton-Dickinson (BD) informed the FDA that it is no longer using the rubber stopper material associated with loss of drug potency in its general use syringes, and BD has instead returned to a rubber stopper it used previously in the syringes. In 2015, FDA initially alerted healthcare professionals not to administer compounded and repackaged drugs stored in certain sizes of general use BD syringes, based on reports of an interaction with the rubber stopper that caused some drugs stored in these syringes to lose potency when not used immediately.
Learn more about BD syringes rubber stoppers replacement
Illegal, Unapproved Opioid Cessation Products
The FDA and FTC posted joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal. The companies are directed to inform each agency of the specific actions taken to address each agency’s concerns. The warning letters also state that failure to correct violations may result in law enforcement action such as seizure or injunction.
Learn more about illegal, unapproved opioid cessation products
Invega Sustenna Drug Labeling
The FDA has approved the inclusion of phase 3 study data in product labeling for the once-monthly schizophrenia treatment Invega (paliperidone palmitate). The randomized Paliperidone Palmitate Research In Demonstrating Effectiveness (PRIDE) trial comprised patients not usually included in clinical research. All 444 adult patients had schizophrenia and had been taken into custody and jailed at least once in the previous 2 years. The PRIDE study demonstrated the superior effectiveness in delaying time to relapse and also demonstrated that the time to first psychiatric hospitalization or arrest and/or incarceration was significantly longer for people treated with Invega Sustenna versus commonly prescribed oral antipsychotics. The treatment is the first and only antipsychotic to have the FDA approve the inclusion of real-world data in its product labeling.
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The FDA is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package of Imodium (loperamide) to help foster safe use. This is due to the FDA continuing to receive reports of serious heart problems and deaths with much higher than the recommended doses, primarily among people who are intentionally misusing or abusing the product, despite the addition of a warning to the medicine label and a previous communication.
Learn more about loperamide packaging
Ocaliva Boxed Warning
The FDA has added a Boxed Warning and dosing table to the label of the liver disease drug Ocaliva (obeticholic acid) to reinforce appropriate dosing. The action follows reports that Ocaliva has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis, increasing the risk for serious liver injury. In addition to the Boxed Warning and dosing table, the FDA is also requiring a Medication Guide for patients to inform them about this issue.
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Opioid Compounds in Kratom
A new analysis by FDA scientists shows that compounds in kratom act like prescription-strength opioids. Kratom has now been linked to 44 deaths, up from 36 reported in November 2017.
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Opioid Cough and Cold Medicines Labeling Changes
The FDA is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18. The FDA is also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing to the Boxed Warning.
Learn more about opioid cough and cold medicines labeling changes
Varubi Injectable Emulsion Hypersensitivity Reactions
Anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization, during or soon after the infusion of Varubi (rolapitant) injectable emulsion. Most reactions have occurred within the first few minutes of administration.
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