Mylan Receives FDA Approval for Benazepril Hydrochloride Tablets and Benazepril Hydrochloride and Hydrochlorothiazide 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.
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 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.
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|Date:||Feb 11, 2004|
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