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Alembic Pharmaceuticals receives USFDA approval for Amantadine Hydrochloride Capsules

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amantadine Hydrochloride Capsules, USP, 100mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Symmetrel Capsules, 100mg, of Endo Pharmaceuticals Inc. Amantadine Hydrochloride Capsules have an estimated market size of $37 million for twelve months ending December 2016, according to IMS.

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