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Aurobindo Pharma Limited announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Zolmitriptan Tablets, 2.5 mg and 5 mg. This product is expected to be launched in Q2 FY16-17.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Zomig® Tablets, 2.5 mg and 5 mg tablets, of IPR Pharmaceuticals, Inc.
Zolmitriptan Tablets is used in the acute treatment of migraine with or without aura in adults. The approved product has an estimated market size of US$ 46.7 million for the twelve months ending March 2016 according to IMS.
This is the 76th ANDA (including 16 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 260 ANDA approvals (223 Final approvals including 11 from Aurolife Pharma LLC and 37 tentative approvals) from USFDA.
