Mylan Receives FDA Approval for Generic Version of Thyroid Deficiency Treatment Cytomel(R)Begins shipment of products
PITTSBURGH, July 16 /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 Liothyronine Sodium Tablets USP, 5 mcg (base),
25 mcg (base) and 50 mcg (base).
Liothyronine Sodium Tablets are the generic version of King
Pharmaceuticals' thyroid deficiency treatment Cytomel , which had total U.S.
sales of approximately $54 million for the 12 months ending March 31 for the
same strengths, according to IMS Health. Mylan has begun to ship this product.
Currently, Mylan has 120 ANDAs pending FDA approval representing $84.7
billion in annual brand sales, according to IMS Health. Thirty-five of these
pending ANDAs are potential first-to-file opportunities, representing $16.6
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: Media; Michael Laffin, +1-724-514-1968, or Investors; Dan
Crookshank, +1-724-514-1813, both of Mylan Inc.