Alembic Pharmaceuticals receives USFDA approval for Zolmitriptan Tablets

05 Dec 2016 Evaluate

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Zolmitriptan Orally Disintegrating Tablets, 2.5 mg and 5 mg. Zolmitriptan orally disintegrating tablets had an estimated market size of $14 million for twelve months ending December 2015, according to IMS.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Zomig-ZMT Orally Disintegrating Tablets, 2.5 mg and 5 mg, of AstraZeneca Pharmaceutical Company. Zolmitriptan orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company manufactures and markets generic pharmaceuticals products all over the world. It now has a total of 51 ANDA approvals (45 Final approvals and 6 tentative approvals) from USFDA.



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