Mylan Laboratories Inc. Announces Tentative Approval For Amlodipine Besylate And Benazepril Hydrochloride Capsules
PITTSBURGH, July 13 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that the U.S. Food and Drug Administration has granted tentative approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for Amlodipine Besylate and Benazepril Hydrochloride Capsules, 2.5 mg (base)/10 mg, 5 mg (base)/10 mg, 5 mg (base)/20 mg and 10 mg (base)/20 mg.
Amlodipine Besylate and Benazepril Hydrochloride Capsules are indicated for the treatment of hypertension. They are the generic version of Novartis' Lotrel(R) Capsules, which had annual U.S. sales of approximately $1.3 billion for the 12 months ending March 31, 2006.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries: Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.
For more information about Mylan, please visit www.mylan.com.
Mylan Laboratories Inc.CONTACT: Patrick Fitzgerald, or Kris King, +1-724-514-1800, of MylanLaboratories Inc.
Web site: http://www.mylan.com//