August 16, 2021
August 16, 2021 – Pfizer has recalled an additional four lots of Chantix® (varenicline) after identifying a nitrosamine impurity, N-nitroso-varenicline, above the manufacturer’s established acceptable
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Pharmaceutical News
August 16, 2021
August 16, 2021 – The U.S. FDA has approved Merck’s WeliregTM (belzutifan), the first hypoxia-inducible
factor-2 alpha (HIF-2α) inhibitor to become
August 13, 2021
August 13, 2021 – The U.S. FDA has expanded approval for Mirena® (levonorgestrel-releasing intrauterine
system), an intrauterine device (IUD) manufactured by Bayer, to prevent pregnancy
August 13, 2021
August 13, 2021 – TicoVacTM (tick-borne encephalitis vaccine), manufactured by Pfizer, has received FDA approval to provide active immunization to prevent
August 12, 2021
August 12, 2021 – The U.S. FDA has approved a new indication for Xywav® (calcium/magnesium/
potassium/sodium oxybates) oral solution
August 12, 2021
August 12, 2021 – Cipla has received final approval from the U.S. FDA for its generic version of Durezol® (difluprednate ophthalmic emulsion – Novartis) 0.5%.
August 12, 2021
August 12, 2021 – The U.S. FDA has modified the emergency use authorization (EUA) for both the Pfizer
August 10, 2021
August 10, 2021 – SterRx, LLC, has recalled three lots of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000mL to the hospital pharmacy level as a result of waterborne