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.
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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.
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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.
