Consumer Goods, Healthcare - Thursday, November 12, 2009 11:19 - 0 Comments

Mylan Inc. (MYL), Mylan gets FDA approval for generic Prevacid

Matrix Laboratories Limited, the Indian subsidiary of Mylan Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of the heartburn drug Prevacid. This product will be sold under the Mylan Pharmaceuticals brand and will be shipped immediately.

These Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-release (DR) Capsules will come in 15 mg and 30 mg versions.

Lansoprazole DR Capsules are the generic version of Tap Pharmaceuticals’ proton pump inhibitor Prevacid® DR Capsules. According to IMS Health, the brand product had U.S. sales of approximately $3 billion for the 12 months ending June 30.

Still according to IMS Health, Mylan currently has 125 ANDAs pending FDA approval representing $84.1 billion in annual brand sales. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing $19.2 billion in annual brand sales, for the 12 months ending June 30.

Mylan Inc. is one of the leading generic and specialty pharmaceutical companies in the world. It provides products to customers in more than 140 countries and territories. It also has one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline. Mylan Inc. operates the world’s third largest active pharmaceutical ingredient manufacturer; and runs a specialty business focused on respiratory and allergy therapies.