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Aurobindo Receives Approval for Sumatriptan Naproxen Sodium Tabs

Published: February 15, 2018

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Sumatriptan and Naproxen Sodium Tablets, 85 mg/500 mg. Aurobindo’s Sumatriptan and Naproxen Sodium Tablets are an AB-rated generic equivalent to the reference listed drug Treximet®.

Sumatriptan and Naproxen Sodium tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.

 

The product has an estimated market size of $102.2M for the twelve months ending December 2017 according to IMS*.

 

Sumatriptan and Naproxen Sodium represent the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 290 final approvals, including 38 tentative approvals, and 17 approved products from Aurolife. There are 105 additional products on file with U.S. FDA.

 

* IMS National Sales Perspectives: Retail and Non-Retail MAT December 2017