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Matrix Labs gets US FDA approval for nabumetone tablets

Our Bureau, MumbaiThursday, July 15, 2010, 08:00 Hrs  [IST]

Matrix Laboratories, a subsidiary of Mylan Inc, has received final approval from the US FDA for its ANDA for nabumetone tablets USP, 500 mg and 750 mg. The product was determined to be bioequivalent and, therefore, therapeutically equivalent to nabumetone tablets, a treatment for osteoarthritis and rheumatoid arthritis. The product will be distributed by Mylan Pharmaceuticals Inc. As per IMS Health, nabumetone tablets had US sales of approximately $68 million for the 12 months ending March 31, 2010. Currently, Mylan has 134 ANDAs pending FDA approval representing $93.8 billion in annual brand sales, according to IMS Health. Thirty-nine of these pending ANDAs are potential first-to-file opportunities, representing $20.2 billion in annual brand sales, for the 12 months ending December 31, 2009 according to IMS Health. Mylan ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies.

 
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