BackAurobindo Pharma gets FDA approval to sell migraine drug in US
The product, which will be launched by Aurobindo in the second quarter of FY 17, had an estimated market size of $446.7 million
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Hyderabad: Indian drugmaker Aurobindo Pharma Ltd has won approval from the US Food and Drug Administration (FDA) to sell migraine drug Zolmitriptan in the US, the company said on Friday.
IPR Pharmaceuticals, Inc. is the innovator of the drug which it sells under the brand name Zomig.
The product, which will be launched by Aurobindo in the second quarter of FY 17, had an estimated market size of $446.7 million in the 12 months ended March 2016, according to US based healthcare data vendor IMS.
The product will be sold in 2.5 mg and 5 mg dosages.
The drug will be manufactured at the company’s Unit VII formulation facility in Hyderabad, which makes oral non-antibiotic products.
Aurobindo now has won 76 abbreviated new drug applications (ANDA) for the facility. Altogether it has a total of 260 ANDA approvals, of which 223 are final approvals and 37 tentative approvals, from the FDA.
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