You are here

FDA Approves Generic Lotensin Tablets

PITTSBURGH--(BUSINESS WIRE)--Feb. 11, 2004--Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval for Mylan Pharmaceuticals' Abbreviated New Drug Application (ANDA) for Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg, and 40 mg. Benazepril Hydrochloride is the generic version of Novartis Pharmaceuticals' Lotensin(R) Tablets.

Additionally, the FDA granted final approval for Mylan's ANDA for Benazepril Hydrochloride and Hydrochlorothiazide Tablets, 5 mg/6.25 mg, 10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 mg. Benazepril Hydrochloride and Hydrochlorothiazide Tablets are the generic version of Novartis Pharmaceuticals' Lotensin HCT(R) Tablets.

Mylan is prepared to launch Benazepril Hydrochloride Tablets and Benazepril Hydrochloride and Hydrochlorothiazide Tablets beginning today.

Source: Mylan Laboratories Inc.

Recent Headlines

NY Hospitals Required to Implement Protocols in Suspected Cases
Presence of BOK Protein Key for Positive Treatment Response
Patient Access to Inhaler Use Data Could Improve Asthma Management
Overall Survival 4.3 Months’ vs. 1.5 Months for Traditional Regimens
Primary Immunodeficiencies Affect 250,000 People in U.S.
More Than 25% of Patients Responded to Xpovio/Dexamethasone Combo
Attacks Cancerous Cells, Leaves Healthy Tissues Alone
Moderates Pre-diabetes Progression, Reduces Cholesterol Levels