Mylan's Matrix Receives Final FDA Approval for the Generic Version of the Antiretroviral Zerit(R) CapsulesPITTSBURGH,
Dec. 30 /PRNewswire-FirstCall/ --
Mylan Inc. (Nasdaq: MYL)
today announced that
Matrix Laboratories Limited, its
India-based subsidiary
in which it holds a 71.5% controlling interest, received final approval from
the
U.S. Food and Drug Administration (FDA) on
December 29, for its
Abbreviated New Drug Application (ANDA) for Stavudine Capsules USP, 15 mg, 20
mg, 30 mg and 40 mg.
Stavudine Capsules, indicated for the treatment of HIV-1 infection in
combination with other antiretroviral agents, are the generic version of
Bristol-Myers Squibb's Zerit® Capsules. This product had annual U.S. sales
of approximately $54 million for the 12 months ending Sept. 30, 2008, for the
noted strengths, according to IMS Health.
The product was shipped immediately under the Mylan Pharmaceutical Inc.
label.
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.
-0- 12/30/2008
/CONTACT: Michael Laffin (Media), +1-724-514-1968, or Dan Crookshank
(Investors), +1-724-514-1813, both of Mylan Inc./
/Web Site: http://www.mylan.com /
(MYL)
CO: Mylan Inc.; IMS Health; Mylan Pharmaceutical Inc.; Matrix Laboratories
Limited; U.S. Food and Drug Administration
ST: Pennsylvania
IN: MTC HEA
SU: FDA
PR
-- NE54896 --
9996 12/30/2008 08:00 EST http://www.prnewswire.com