Mylan Inc. Says FDA Approves its Generic Risperdal
PITTSBURGH, Sept. 16 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Risperidone Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg.
Risperidone Tablets, used to treat schizophrenia and bipolar disorder, are the generic version of Janssen's Risperdal(R) Tablets. This product had annual U.S. sales of approximately $2.67 billion for the 12 months ending June 30, 2008, for the noted strengths, according to IMS Health.
Mylan will ship the product shortly. Currently, the company has 109 ANDAs pending FDA approval, 22 of which are potential first-to-file opportunities.
Mylan Inc., with a presence in more than 120 countries, 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 second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.
CONTACT: Media: Michael Laffin, or Investors: Dan Crookshank, both at
Web site: http://www.mylan.com/