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Aurobindo Pharma receives FDA approval for Gabapentin tablets

Aurobindo Pharma has received final approval from US Food and Drug Administration (USFDA) to manufacture and market in 600mg and 800mg tablets of Gabapentin. Gabapentin is a generic equivalent of Pfizer Pharmaceuticals’ Neurontin tablets which are indicated in treatment of partial seizures and nervous system disorder. The US Gabapentin market is supposed to be US$220 Million for twelve months ending June 2011 according IMS.  

In fact we called up the company to get more insights on this announcement. Though the company spokesperson declined to comment on the revenue potential of this product, he did say that the company is expected to launch this product in this quarter and is ambitious to tap 10-15 per cent market share in USA.

That apart, Aurobindo pharma now has a pipeline of 139 ANDA approvals which includes 110 final approvals and 29 tentative approvals from USFDA.

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