USFDA nod to Aurobindo Pharma's generic Zolmitriptantab for migraine
New Delhi : 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.
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 USD 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 per cent from the previous close.