Mylan Receives FDA Approval for Additional Strength of Generic Restoril(R)Product shipment has begun
PITTSBURGH, June 17 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL)
today announced that its subsidiary Mylan Pharmaceuticals Inc. has received
approval from the U.S. Food and Drug Administration (FDA) for its supplemental
Abbreviated New Drug Application (ANDA) for Temazepam Capsules USP, 22.5 mg.
This strength is in addition to Mylan's currently marketed 15 mg and 30 mg
strengths of the product.
Temazepam Capsules are the generic version of Mallinckrodt's Restoril®,
a sleep aid, which had total U.S. sales of approximately $6 million for the 12
months ending March 31, according to IMS Health. Mylan has begun shipping this
product.
Currently, Mylan has 118 ANDAs pending FDA approval representing $82.7
billion in annual brand sales, according to IMS Health. Thirty-five of these
pending ANDAs are potential first-to-file opportunities, which represent $16.7
billion in annual brand sales, according to IMS Health.
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 www.mylan.com.
SOURCE Mylan Inc.
06/17/2009
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 MYL)