Aurobindo Pharma gets USFDA nod for generic migraine drug
With this approval, the company has now a total of 260 abbreviated new drug application (ANDA) approvals from the USFDA
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Aurobindo Pharma has received approval from the US health regulator to sell generic Zolmitriptan tablets, a drug used to treat migraine, in the American market.
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Zolmitriptan Tablets in strengths of 2.5 mg and 5 mg, Aurobindo Pharma said in a regulatory filing.
"This product is expected to be launched in second quarter of FY16-17," it added.
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The company's product is the generic equivalent of IPR Pharmaceuticals' Zomig, which is used in the treatment of migraine in adults.
"The approved product has an estimated market size of $46.7 million for the 12 months ending March 2016 according to IMS," Aurobindo Pharma said.
With this approval, the company has now a total of 260 abbreviated new drug application (ANDA) approvals from the USFDA.
Aurobindo shares were trading at Rs 789.45 on BSE, down 1.48% from the previous close.
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First Published: May 13 2016 | 3:28 PM IST
