Mylan Inc announced that its subsidiary Mylan Pharma -ceuticals Inc received final approval from the US Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for Omeprazole Delayed-release (DR) capsules USP, 40 mg, and the generic version of AstraZeneca's Prilosec DR Capsules.
ReadmOmeprazole DR Capsules are indicated for the treatment of peptic ulcers and gastroesophageal reflux disease (GERD). This product had annual US sales of approximately $211 million for the 12 months ending September 30, 2008, for the 40 mg strength according to IMS Health.
Mylan Pharmaceuticals is shipping this product immediately.
Mylan, 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.