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news.Matrix Laboratories, a subsidiray of Mylan, has received FDA final approval for its abbreviated new drug application (ANDA) for Gabapentin tablets 600mg and 800mg, the generic version of Pfizer's Neurontin tablets, for the treatment of postherpetic neuralgia, a complication of shingles. The product will be distributed by Mylan Pharmaceuticals.
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Gabapentin is an anti-epileptic medication, also called an anticonvulsant. It is used alone or in combination with other medications to treat seizures caused by epilepsy in adults and children who are at least 12 years old. Gabapentin is also used to treat nerve pain caused by herpes virus or shingles (herpes zoster).
Mylan currently has 140 ANDAs pending FDA approval representing $95.5bn in annual brand sales, according to IMS Health. 40 of these pending ANDAs are first-to-file opportunities, representing 21bn in annual brand sales, for the 12 months ending December 31, 2009.