SPRING VALLEY, N.Y., Aug. 29 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Applications for cholestyramine for oral suspension, 4g resin/9g powder and cholestyramine for oral suspension, (light), 4g resin/5g powder. Cholestyramine is the generic version of Bristol-Myers Squibb Company’s Questran(R) Powder and Questran(R) Light Powder for Oral Suspension, and is used for the treatment of primary hypercholesterolemia. U.S. sales of cholestyramine products are approximately $50 million, according to IMS health. Cholestyramine for oral suspension (regular and light), will be available in multiple-dose containers providing 4g resin/scoopful and single- use packets containing 4g resin/packet. Par will begin shipping the products shortly.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc. The company is also developing an additional line of branded pharmaceutical products, the first of which is Megace(R) ES, for specialty markets. Par currently manufactures, markets or licenses more than 90 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.
CONTACT: Stephen J. Mock, or Cecelia C. Heer, both for Par PharmaceuticalCompanies, Inc., +1-201-802-4000
Web site: http://www.parpharm.com/
