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    Alembic Pharma Gets USFDA Approval for Paroxetine ER Tablets

    Alembic Pharmaceuticals Limited (Alembic) today announced that 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 the reference listed drug product (RLD), Paxil CR Tablets, 12.5 mg, of Apotex Inc.