Alembic Pharmaceuticals Secures USFDA Approval for Generic Paroxetine Extended-Release Tablets
Approval Strengthens Alembic’s US Generics Portfolio
New Delhi, March 30: Alembic Pharmaceuticals Ltd on Monday announced that it has received final approval from the United States Food and Drug Administration for its generic version of Paroxetine extended-release tablets, used in the treatment of multiple mental health conditions.Details of the USFDA Approval
The approval pertains to the company’s supplemental Abbreviated New Drug Application for Paroxetine extended-release tablets in the 12.5 mg strength, according to a statement issued by Alembic Pharmaceuticals.The approved product has been deemed therapeutically equivalent to the reference-listed drug Paxil CR Tablets, 12.5 mg, marketed by Apotex Inc.
Indications and Medical Use
Paroxetine extended-release tablets are prescribed for a range of psychiatric conditions. These include major depressive disorder, panic disorder, social anxiety disorder, and premenstrual dysphoric disorder.The latest approval marks another addition to Alembic Pharmaceuticals’ portfolio in the US generics market, expanding its presence in the regulated pharmaceutical segment.
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