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  • FDA Drug Updates

    FDA New Approvals

    Alaway

    The FDA has approved Alaway Preservative Free (ketotifen fumarate) ophthalmic solution, 0.035%, antihistamine eye drops, as the first over-the-counter, preservative-free formulation eye drop approved to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander. Learn more about Alaway

    Alkindi Sprinkle

    The FDA has approved Alkindi Sprinkle (hydrocortisone oral granules) as replacement therapy in pediatric patients with adrenocortical insufficiency. Alkindi Sprinkle is a patented, oral, immediate-release formulation of hydrocortisone granules in capsules designed for children. Alkindi Sprinkle comes in dose strengths consistent with age-appropriate dosing in children. Learn more about Alkindi Sprinkle

    FDA New Indications

    Nucala

    The FDA has approved Nucala (mepolizumab) for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome for ≥6 months without an identifiable non-hematologic secondary cause. The approval makes Nucala the first and only targeted biologic treatment to be approved for patients with this eosinophil-driven disease in the US. Learn more about Nucala

    Opdivo plus Yervoy

    Opdivo (nivolumab) 360mg every three weeks plus Yervoy (ipilimumab) 1mg/kg every six weeks (injections for intravenous use) was approved by the FDA for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. This is the third indication for an Opdivo plus Yervoy-based combination in the first-line treatment of a form of thoracic cancer. Learn more about Opdivo plus Yervoy

    Simponi Aria

    The FDA has approved Simponi Aria (golimumab) for patients aged 2 years and older for the treatment of active polyarticular juvenile idiopathic arthritis and has extended the active psoriatic arthritis indication for this same patient population. Learn more about Simponi Aria

    FDA Recalls

    Acella Pharmaceuticals NP Thyroid

    Acella Pharmaceuticals is voluntarily recalling one lot of 15mg and one lot of 120mg NP Thyroid, thyroid tablets, USP (levothyroxine [T4] and liothyronine [T3]) to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have as low as 87% of the labeled amount of levothyroxine (T4). Learn more about the Acella Pharmaceuticals NP Thyroid recall

    Marksans Pharma Limited Metformin Hydrochloride Extended-Release Tablets

    Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of metformin hydrochloride extended-release tablets, USP 500mg, and 750mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable daily intake limit of 96ng/day; therefore, out of an abundance of caution, an additional 76 lots are being recalled. Learn more about the Marksans Pharma Limited metformin hydrochloride extended-release tablets recall

    Perrigo Albuterol Inhaler

    The FDA is alerting healthcare professionals and patients of a voluntary recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma Solutions for Perrigo Pharmaceutical Company, due to possible clogging of the inhaler resulting in patients not receiving enough or any medicine. This recall is to the retail level. The FDA urges patients to continue using the inhaler they have on hand. Learn more about the Perrigo albuterol inhaler recall

    Sun Pharmaceutical Riomet ER

    Sun Pharmaceutical Industries is voluntarily recalling one lot of Riomet ER (metformin hydrochloride for extended-release oral suspension), 500mg per 5mL, to the consumer level. The recall is due to the level of N-Nitrosodimethylamine, which has been found to be above the allowable acceptable daily intake limit established by the FDA. Learn more about the Sun Pharmaceutical Riomet ER recall

    FDA Alerts

    Benadryl

    The FDA is warning that taking higher than recommended doses of the common over-the-counter allergy medicine Benadryl (diphenhydramine) can lead to serious heart problems, seizures, coma, or even death. The FDA is aware of news reports of teenagers ending up in emergency rooms or dying after participating in the “Benadryl Challenge” encouraged in videos posted via social media. Learn more about Benadryl

    Benzodiazepines

    The FDA is requiring the Boxed Warning, the agency’s most prominent warning, to be updated and adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions consistently across all the medicines in the class. The FDA is also requiring updates to the existing patient Medication Guides to help educate patients and caregivers about these risks. Learn more about benzodiazepines

    FDA’s Do-Not-Use Hand Sanitizer List

    The FDA recommends checking its do-not-use hand sanitizer list maintained online. The list is updated regularly as new test results are released. Recent additions include instances of sanitizers containing methanol and subpotent for ethanol. The FDA is warning consumers and healthcare providers that the agency has seen a sharp increase in hand sanitizer products labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. The agency is aware of people ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events, including blindness, hospitalizations, and death. Methanol is not an acceptable ingredient for hand sanitizers and must not be used due to its toxic effects. Learn more about the FDA’s do-not-use hand sanitizer list

    Makena

    The FDA's Center for Drug Evaluation and Research proposed that Makena (hydroxyprogesterone caproate injection) be withdrawn from the market because the required postmarket study failed to verify clinical benefit and has concluded that the available evidence does not show Makena is effective for its approved use. Makena and its approved generic equivalents will remain on the market until the manufacturers decide to remove the drugs or the FDA Commissioner mandates their removal. In the interim, the FDA recommends that healthcare professionals discuss Makena's benefits, risks and uncertainties with their patients to decide whether to use Makena while a final decision is being made about its marketing status. Learn more about Makena