Printer Friendly
The Free Library
14,530,717 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Mylan Receives FDA Approval for Benazepril Hydrochloride Tablets and Benazepril Hydrochloride and Hydrochlorothiazide Tablets.


Business Editors

PITTSBURGH--(BUSINESS WIRE)--Feb. 11, 2004

Mylan Laboratories Inc. (NYSE NYSE

See: New York Stock Exchange
: MYL) today announced that the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has granted final approval for Mylan Pharmaceuticals' Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar  (ANDA ANDA
abbr.
abbreviated new drug application
) 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 hydrochlorothiazide /hy·dro·chlo·ro·thi·a·zide/ (-klor?o-thi´ah-zid) a thiazide diuretic, used for treatment of hypertension and edema.

hy·dro·chlo·ro·thi·a·zide
n. Abbr.
 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 Hct
abbr.
hematocrit


HCT Hematocrit, see there
(R) Tablets.

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

Mylan Laboratories Inc. is a leading pharmaceutical company with four subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., UDL Laboratories Inc. and Bertek Pharmaceuticals Inc., that develop, manufacture and market an extensive line of generic and proprietary products.

For more information about Mylan, visit www.mylan.com.

This press release includes statements that constitute "forward-looking statements," including with regard to the launch of Benazepril. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the possible negative effects of any interruption of manufacture of the Tablets at the Company's facility; uncertainties regarding market acceptance and demand for Benazepril; dependence on third-party suppliers and distributors for raw materials; and the other risks detailed in the Company's filings with the Securities and Exchange Commission. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:Feb 11, 2004
Words:315
Previous Article:Eon Labs Receives Final Approval for Benazepril HCl Tablets and Benazepril HCl/HCTZ Tablets and Will Begin Shipping Immediately.
Next Article:DVCon 2004 Announces Final Program with Ray Bingham to Provide Keynote.
Topics:



Related Articles
Taking your medicine. (includes related information)(Hypertension)
Somerset Initiates Legal Action Against FDA.
Mylan Receives Approval for Buspirone 15 mg.
Consumer class actions follow suits by generic drug makers against brand-name companies.
Antihypertensive Medications. (Featured CME Topic: Hypertension).
Teva Announces Tentative Approval of Benazepril HCL Tablets, 5 Mg, 10 mg, 20 mg, and 40 mg.
Teva Announces Final Approval of Benazepril HCl Tablets, 5 Mg, 10 Mg, 20 Mg, and 40 Mg.
Andrx Launches Its Generic Versions of Lotensin and Lotensin HCT.
IVAX Receives Final Approval on Benazepril HCl Tablets.
IVAX Receives Final Approval On Benazepril HCl/HCTZ Tablets.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles