FDA Approves Mylan Inc.'s Generic Version of Prilosec
PITTSBURGH, Jan. 23 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for Omeprazole Delayed-release (DR) Capsules USP, 40 mg, the generic version of AstraZeneca's Prilosec(R) DR Capsules.
Omeprazole DR Capsules are indicated for the treatment of peptic ulcers and gastroesophageal reflux disease (GERD). This product had annual U.S. sales of approximately $211 million for the 12 months ending Sept. 30, 2008, for the 40 mg strength according to IMS Health.
Mylan Pharmaceuticals is shipping this product immediately.
Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com.
CONTACT: Michael Laffin (Media), +1-724-514-1968; Dan Crookshank
Web site: http://www.mylan.com/