Alembic Pharmaceuticals Receives USFDA Final Approval for Paroxetine Extended-Release Tablets
Alembic Pharmaceuticals Limited announced it has received final approval from the US Food & Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) Paroxetine Extended-Release Tablets USP, 12.5 mg. The approved sANDA is therapeutically equivalent to Paxil CR Tablets, 12.5 mg, of Apotex Inc.Paroxetine extended-release tablets are indicated for the treatment of Major depressive disorder (MDD), Panic disorder (PD), Social anxiety disorder (SAD), and Premenstrual dysphoric disorder (PMDD). Refer label for a detailed indication.
Alembic Pharmaceuticals has a cumulative total of 235 ANDA approvals, comprising 216 final approvals and 19 tentative approvals, from USFDA.
Alembic Pharmaceuticals Limited, founded in 1907, is a vertically integrated research and development pharmaceutical company. The company manufactures and markets generic pharmaceutical products globally. Alembic’s manufacturing facilities are approved by regulatory authorities in developed countries, including the USFDA. The company is a leader in branded generics in India, marketing products through a field force of over 5500.
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