FDA New Approvals
The FDA has approved Cabenuva (cabotegravir and rilpivirine) as a treatment for HIV-1 infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. This is the first FDA-approved injectable, complete regimen for HIV-infected adults that is administered once a month.
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The FDA has approved Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). Lupkynis is the first FDA-approved oral therapy for LN.
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The FDA has approved Posimir (bupivacaine solution) for infiltration use in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. The approval was based on positive data from a randomized, multicenter, assessor-blinded, placebo–controlled clinical trial in patients undergoing arthroscopic subacromial decompression surgery with an intact rotator cuff.
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The FDA has approved Tepmetko (tepotinib) following Priority Review for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition exon 14 skipping alterations. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
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The FDA has approved Verquvo (vericiguat), a soluble guanylate cyclase stimulator, to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. Verquvo is the first treatment for chronic heart failure approved specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics.
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The FDA has approved Vocabria (cabotegravir, tablet formulation), which should be taken in combination with oral rilpivirine (Edurant) for one month prior to starting treatment with the also approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) to ensure the medications are well-tolerated before switching to the extended-release injectable formulation.
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Apotex Enoxaparin Sodium
Apotex is voluntarily recalling two batches of enoxaparin sodium injection, USP to consumer level due to a packaging error resulting in some syringes barrels containing 150mg/mL markings (corresponding to 120mg/0.8mL strength) instead of 100mg/mL markings (corresponding to 100mg/mL strength) on the syringe barrel and vice versa. The packaging error was discovered during a customer complaint investigation.
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Meitheal Pharmaceuticals Cisatracurium Besylate
Meitheal Pharmaceuticals announced that it is voluntarily recalling one lot of cisatracurium besylate Injection, USP 10mg per 5mL to the user level. The decision to recall the product was made after a product complaint revealed that a portion of Lot C11507A of cartons labeled as cisatracurium besylate injection, USP 10mg per 5mL, containing 10-vials per carton, contained 10-vials mis-labeled as phenylephrine hydrochloride injection, USP 100mg per 10mL. Meitheal has not received reports of any adverse events or identifiable safety concerns attributed to the lot.
Learn more about the Meitheal Pharmaceuticals cisatracurium besylate recall
Nostrum Laboratories Metformin HCl
Nostrum Laboratories is voluntarily recalling one lot of metformin HCl extended release tablets, USP 750mg (generic equivalent to Glucophage tablets) to the consumer level. The metformin HCl extended release tablets, USP 750mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96ng/day, as published in the FDA Guidance Document issued September 2020. This is an expansion of the recall initially announced on November 2, 2020.
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Import Alert for Alcohol-Based Hand Sanitizers from Mexico
The FDA has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the US until the agency is able to review the products’ safety. Over the course of the ongoing pandemic, the agency has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin and life-threatening when ingested. Methanol is not an acceptable ingredient in hand sanitizer or other drugs.
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Policy for Testing of Ethanol and Isopropyl Alcohol for Methanol
The FDA has issued a guidance to notify drug manufacturers, including repackers, relabelers, alcohol suppliers, and compounders, of the FDA’s policy on testing alcohol (ethanol) or isopropyl alcohol for methanol prior to using the ingredient in drugs. This policy applies to any drug with alcohol as an ingredient, including hand sanitizer products, certain inhalation products, mouthwashes, cough and cold products, and many topical drug products.
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Vinca Alkaloid Labeling
The FDA is alerting healthcare professionals to labeling updates for the preparation of vinca alkaloids, a group of chemotherapy agents that includes vincristine sulfate injection, vinblastine sulfate (for) injection, and vinorelbine tartrate injection. To reduce the potential for unintended intrathecal (spinal) administration, which causes death or severe neurological injury, the FDA is working with drug application holders to remove instructions for preparation of these drugs by syringe and to recommend preparation in intravenous infusion bags only.
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Xeljanz Linked to Increased Health Risks
The FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to another type of medicine called tumor necrosis factor inhibitors. The FDA required the safety trial, which also investigated other potential risks including blood clots in the lungs and death. Those final results are not yet available.
Learn more about Xeljanz being linked to increased health risks