Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Gabapentin Tablets USP, 600 mg and 800 mg, 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 Inc.
Gabapentin Tablets had U.S. sales of approximately $174 million for the 12 months ending March 31, 2010, according to IMS Health.
Currently, Mylan has 140 ANDAs pending FDA approval representing $95.5 billion in annual brand sales, according to IMS Health. Forty of these pending ANDAs are potential first-to-file opportunities, representing 21 billion in annual brand sales, for the 12 months ending Dec. 31, 2009 according to IMS Health.