Par Pharmaceutical Receives Final Approval to Market Clonazepam Orally Disintegrating Tablets
Posted on: Wednesday, 3 August 2005, 21:00 CDT
SPRING VALLEY, N.Y., Aug. 3 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced that its wholly-owned subsidiary, Kali Laboratories, Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for clonazepam orally disintegrating tablets (ODT). Par's clonazepam ODT is the first generic version of the anticonvulsant Klonopin(R) Wafers. Annual U.S. sales of Klonopin(R) Wafers are approximately $18 million. Par will begin shipping the product immediately.
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 of Par PharmaceuticalCompanies, Inc., +1-201-802-4000
Web site: http://www.parpharm.com/
Source: PRNewswire-FirstCall
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