Mylan Receives Final FDA Approval for Generic Version of Prilosec(R) Delayed-Release Capsules, 40 mgPITTSBURGH,
Jan. 23 /PRNewswire-FirstCall/ --
Mylan Inc. (Nasdaq: MYL)
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
® 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.
SOURCE Mylan Inc.
01/23/2009
/CONTACT: Michael Laffin (Media), +1-724-514-1968; Dan Crookshank
(Investors), +1-724-514-1813
/Web Site: http://www.mylan.com
(MYL)