Mylan Receives FDA Approval for Additional Strengths of the Antipsychotic Haloperidol

 

Mylan Receives FDA Approval for Additional Strengths of the Antipsychotic Haloperidol

PITTSBURGH, July 20 /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 Haloperidol Tablets USP, 10 mg and 20 mg. These strengths are in addition to Mylan's currently marketed 0.5 mg, 1 mg, 2 mg and 5 mg strengths of the product.

Haloperidol Tablets are an antipsychotic typically used to reduce the symptoms of schizophrenia and uncontrollable tics and outbursts associated with Tourette syndrome. Haloperidol had total U.S. sales of approximately $21 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 119 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.

Suggested Articles

A few years ago, one of our Fierce editors met a Big Pharma R&D chief for the first time. “You’re the ones with the scary name,” he joked.

Pfizer's eczema hopeful has been building its case to challenge Sanofi and Regeneron's Dupixent, but safety issues could stand in its way.

Cedrik Britten, M.D., becomes the biotech’s new chief medical officer to help run its adoptive cell therapy and TCR bispecifics platform.