USFDA nod for Aurobindo drug

Our Bureau Updated - March 12, 2018 at 12:34 PM.

Aurobindo Pharma Ltd has received final approval from the US Food & Drug Administration to manufacture and market Gabapentin tablets. Gabapentin tablets are the generic equivalent of Neurontin tablets of Pfizer Pharmaceuticals. They are indicated for the treatment of partial seizures and other nervous system disorders.

The annual sales of these tablets in the US were approximately $220 million for the twelve months ending June 2011, according to IMS.

Aurobindo now has a total of 139 abbreviated new drug application approvals including 110 final approvals and 29 tentative approvals from the US.

Published on October 12, 2011 12:01