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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
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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