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Ahmedabad: Zydus Lifesciences has expanded its presence in the U.S. generics market with a key regulatory approval for a widely used diabetes treatment. Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration for Dapagliflozin Tablets in 5 mg and 10 mg strengths. This approval enables the company to enter the U.S. market with a generic version of the drug, broadening its portfolio in a high-demand therapeutic category. With the approval, Zydus ...Read More >
New Delhi, Jun 30 (PTI) Alembic Pharmaceuticals on Monday said it has received the final approval from the US health regulator for its generic Doxorubicin Hydrochloride Liposome injection in different types of cancer. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) is for Doxorubicin Hydrochloride Liposome injection of strengths 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) single-dose vials, Alembic Pharmaceuticals said in a statement ...Read More >
New Delhi, Dec 17 (PTI) Drug firm Granules India on Tuesday said its subsidiary has received approval from the US health regulator for a generic medication used to treat attention-deficit hyperactivity disorder. Granules Pharmaceuticals, Inc (GPI) has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Lisdexamfetamine Dimesylate chewable tablets, the drug firm said in a statement. The approved drug is available in multiple stren ...Read More >
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