Mylan Receives Final FDA Approvals for Generic Versions of Anti-Rejection Medication CellCept(R)PITTSBURGH,
May 7 /PRNewswire-FirstCall/ --
Mylan Inc. (Nasdaq: MYL) today
announced that its subsidiary
Mylan Pharmaceuticals Inc. received final
approvals from the
U.S. Food and Drug Administration (FDA) for its Abbreviated
New Drug Applications (ANDAs) for Mycophenolate Mofetil Tablets, 500 mg, and
Mycophenolate Mofetil Capsules, 250 mg.
Mycophenolate Mofetil is the generic name for Roche's CellCept®, which
is indicated for the prevention of organ rejection in patients receiving
kidney, heart or liver transplants. CellCept Tablets, 500 mg, and CellCept
Capsules, 250 mg, had annual U.S. sales of approximately $680 million and $367
million, respectively, for the 12 months ending March 31, 2009, according to
IMS Health. Mylan has commenced shipping both products.
Mylan Inc., which provides products to customers in more than 140
countries and territories, ranks among the leading diversified generics 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 http://www.mylan.com.
SOURCE Mylan Inc.
05/07/2009
CONTACT: Media, Michael Laffin, +1-724-514-1968, or Investors Dan
Crookshank, +1-724-514-1813, both of Mylan Inc.
/Web Site: http://www.mylan.com
(MYL)