A comprehensive view of Amneal Pharmaceuticals LLC. This page highlights a small sample of our full coverage.
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Amneal recalls four lots of generic vancomycin hydrochloride in pack sizes 80 mL, 300 mL and 150 mL due to potential overfilling during manufacturing; error could result in excessive dosing
Published:
March 29, 2024
by FiercePharma
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FTC files an amicus brief alleging that Teva improperly listed patents on its ProAir HFA asthma inhaler in the FDA Orange Book, blocking Amneal's approval for a generic version; the FTC is seeking a court judgement to make Teva retract the patents
Published:
March 25, 2024
by FiercePharma
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Amneal reports it launched 39 new retail and injectable products in 2023, including 13 in Q4 2023; new products include potassium phosphate vials, tranexamic acid and esmolol intravenous bags, spironolactone suspension with 180-day exclusivity and others
Published:
January 05, 2024
by Business Wire
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Amneal gets FDA approval for injectable calcium gluconate in sodium chloride, 1000 mg/50 mL and 2000 mg/100 mL, a drug on the FDA shortage list; the firm also received a Competitive Generic Therapy approval designation with 180-day exclusivity
Published:
September 07, 2023
by Business Wire
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FDA denies approval for Amneal's IPX203, an oral formulation to treat Parkinson’s disease due to inadequate safety data; the rejection affects Amneal’s goal for a midyear launch with potential peak sales opportunity of US$500M in the US
Published:
July 06, 2023
by FiercePharma
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