Mylan Receives FDA Approval for Generic Version of Migraine Treatment Imitrex(R)The company is shipping immediately
PITTSBURGH, Aug. 10 /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 Abbreviated
New Drug Application (ANDA) for Sumatriptan Succinate Tablets, 25 mg (base),
50 mg (base) and 100 mg (base). This product is manufactured in Mylan's
Morgantown, W.Va. facility.
Mylan Chairman and CEO Robert J. Coury said: "This particular approval is
especially important at this time on top of the many other approvals
supporting our Morgantown facility and its exemplary 48-year track record of
delivering high quality products to our customers and patients from one of the
largest pharmaceutical manufacturing plants in the word. I would like to again
thank all of Mylan's hardworking employees for their continued dedication to
product quality and safety."
Mylan's Sumatriptan Succinate Tablets are the generic version of
GlaxoSmithKline's migraine treatment Imitrex . This product had total U.S.
sales of approximately $934 million for the 12 months ending June 30 for the
same strengths, according to IMS Health. Mylan is shipping immediately.
Currently, Mylan has 120 ANDAs pending FDA approval representing $85.6
billion in annual brand sales, according to IMS Health. Thirty-four of these
pending ANDAs are potential first-to-file opportunities, representing $17.3
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.
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