SPRING VALLEY, N.Y., Dec. 22 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced that its licensing partner, Amide Pharmaceutical, Inc., has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for quinapril hydrochloride (HCl) tablets. The product was developed by Par's wholly-owned subsidiary, Kali Laboratories, Inc. Quinapril HCl, an angiotensin-converting enzyme (ACE) inhibitor, is the generic version of Pfizer's Accupril(R) and is used primarily for the treatment of hypertension. In 2003, U.S. sales of Accupril(R) were approximately $400 million.
Under the terms of the agreement, Par has exclusive rights to market, sell and distribute quinapril HCl tablets manufactured by Amide. Amide will receive a share of the profits from the sales of the product. Par will begin shipping quinapril HCl tablets immediately, and they will be available in 5 mg, 10 mg, 20 mg and 40 mg strengths.
Amide Pharmaceutical, Inc., located in Little Falls, New Jersey, develops, manufactures and markets a select line of high quality pharmaceuticals.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc., and its recently acquired subsidiary, Kali Laboratories, Inc. The company is also developing an additional line of branded pharmaceutical products for specialty markets and expects to introduce the first of these in 2005. Through its FineTech subsidiary, Par also develops and utilizes synthetic chemical processes to design and develop intermediate ingredients used in the production of finished products for the pharmaceutical industry. Par currently manufactures, markets or licenses more than 80 prescription drugs. For press release and other company information, visit http://www.parpharm.com/.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward- looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, Form 10-Q, and Form 8-K reports.
Par Pharmaceutical Companies, Inc.