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  • FDA Drug Updates

    FDA New Approvals


    The FDA has approved Gvoke (glucagon) injection, a ready-to-use, room-temperature stable liquid glucagon for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 2 years and older. Gvoke is the first glucagon product approved that can be administered via a prefilled syringe (Gvoke PFS) or auto-injector (Gvoke HypoPen). Learn more about Gvoke


    The FDA has approved Ibsrela (tenapanor), a 50mg, twice daily oral pill for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. Ibsrela is a minimally-absorbed small molecule that acts locally in the gastrointestinal tract to inhibit the sodium-hydrogen exchanger NHE3, resulting in an increase in bowel movements and a decrease in abdominal pain for IBS-C patients. Learn more about Ibsrela


    The FDA approved Nourianz (istradefylline) tablets, an adenosine receptor antagonist, as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease experiencing “off” episodes such as tremor and difficulty walking. Learn more about Nourianz

    FDA Labeling Changes


    The FDA recently approved changes to Harvoni (ledipasvir and sofosbuvir) labeling to include a new dosage form and use in pediatric patients aged 3 years to less than 12 years. Harvoni is indicated for the treatment of adults and pediatric patients aged 3 years and older with chronic hepatitis C virus. Harvoni is available as tablets or pellets for oral use. Learn more about Harvoni


    The FDA approved Sirturo (bedaquiline) tablets as part of combination therapy in the treatment of adult and pediatric patients (aged 12 years to less than 18 years and weighing at least 30kg) with pulmonary multi-drug resistant tuberculosis. Sirturo should be reserved for use when an effective treatment regimen cannot otherwise be provided. Learn more about Sirturo


    The FDA recently approved changes to Sovaldi (sofosbuvir) labeling to include a new dosage form and use in pediatric patients aged 3 years to less than 12 years. Sovaldi is indicated for the treatment of chronic hepatitis C virus genotype 2 or 3 infection in pediatric patients aged 3 years and older without cirrhosis or with compensated cirrhosis for use in combination with ribavirin. Sovaldi is available as tablets or pellets for oral use. Learn more about Sovaldi


    The FDA approved changes to the Tybost (cobicistat) tablet labeling to expand the patient population for Tybost coadministered with atazanavir to include pediatric patients with HIV-1 infection who weigh at least 35kg. This change is supported by safety and efficacy data in virologically suppressed pediatric patients with HIV-1 from Clinical Trial GS-US-216-0128 (Trial 128). Learn more about Tybost

    FDA New Indications


    The FDA has approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. It is the first FDA-approved treatment for this rare lung condition. Learn more about Ofev


    The FDA has approved the interleukin-17A inhibitor Taltz (ixekizumab) for the treatment of adults with active ankylosing spondylitis, also known as radiographic axial spondyloarthritis. Learn more about Taltz

    FDA Recalls

    AmEx Pharmacy Bevacizumab

    AmEx Pharmacy is voluntarily recalling of all lots of bevacizumab 1.25mg/0.05mL 31G injectable and all lots of bevacizumab 2.5mg/0.1mL Normject TB injectable that are within expiry, to the healthcare provider level. These lots are being recalled out of an abundance of caution following an FDA inspection. The product involved in this recall is used for wet age-related macular degeneration and diabetic retinopathy. It is individually wrapped and labeled in a Tyvek pouch which is then placed in a labeled amber bag to protect from light. Learn more about the AmEx Pharmacy bevacizumab recall

    Hospira Bacteriostatic Water for Injection

    Hospira, Inc., a Pfizer company, is voluntarily recalling bacteriostatic water for injection, USP, 30mL, multi-dose vial, lot W20308, to the hospital/retail level. Hospira initiated this recall due to lack of confirmation of sterilization for some vials from this lot. Learn more about the Hospira bacteriostatic water for injection recall

    KRS Global Biotechnology Sterile Drugs

    KRS Global Biotechnology is voluntarily recalling all lots of unexpired human and animal drugs intended to be sterile to the consumer level. The products are being recalled due to lack of assurance of sterility. KRS Global Biotechnology is notifying its customers by mail, telephone, or email and is arranging for credit of all recalled products. Learn more about the KRS Global Biotechnology sterile drugs recall

    Plastikon Healthcare Milk of Magnesia

    Plastikon Healthcare is voluntarily recalling milk of magnesia 2400mg/30mL oral suspension, lots 19027D and 19027E, to the patient level. Plastikon Healthcare initiated this recall because these product lots did not meet Plastikon's in-house microbiological specification for total aerobic microbial count. Plastikon Healthcare has notified its direct customers via a recall letter to arrange for return of any recalled product. Learn more about the Plastikon Healthcare milk of magnesia recall

    FDA Alerts

    FDA Alerts About NDMA in Samples of Ranitidine

    The FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. The agency is working with international regulators and industry partners to determine the source of this impurity in ranitidine. Learn more about FDA alert about NDMA in samples of ranitidine

    FDA Warns About Serious Liver Injury with Certain Hepatitis C Medications

    The FDA has received reports that the use of Mavyret (glecaprevir/pibrentasvir), Zepatier (elbasvir/grazoprevir), or Vosevi (sofosbuvir/velpatasvir/voxilaprevir) to treat chronic hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. In most patients, symptoms resolved or new-onset worsening of liver function improved after stopping the medicine. These medicines have been widely used and are safe and effective in patients with no or mild liver impairment. Learn more about FDA warning about serious liver injury with certain hepatitis C medications

    FDA Warning About Lung Inflammation with CDK 4/6 Inhibitors

    The FDA has issued an alert stating that Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs. The FDA has approved new warnings about this risk for the addition of the prescribing information and patient package insert for the entire class of these cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines. The overall benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed. Learn more about FDA warning about lung inflammation with CDK 4/6 inhibitors