Mylan Inc. announced that its subsidiary Matrix Laboratories Limited has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Gabapentin capsules USP, 100 mg, 300 mg and 400 mg, the generic version of Pfizer's Neurontin capsules used to treat a painful complication of shingles.
Gabapentin capsules had US sales of approximately $300 million for the 12 months ending December 31, 2010, according to IMS Health. Mylan Pharmaceuticals Inc. is launching this product immediately.
Currently, Mylan has 169 ANDAs pending FDA approval representing $98.2 billion in annual sales, according to IMS Health. Forty-eight of these pending ANDAs are potential first-to-file opportunities, representing $25.3 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. Their focus is on respiratory, allergy and psychiatric therapies.