Par Pharmaceutical Receives Final Approval To Market Tranylcypromine Sulfate Tablets
Par Pharmaceutical Companies, Inc. (NYSE: PRX) 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 tranylcypromine sulfate tablets, 10 mg. Tranylcypromine is the generic version of GlaxoSmithKline's Parnate(R) and is used for the treatment of depression. Annual U.S. sales of Parnate(R) exceed $6 million. Par will begin shipping the product immediately.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. In 2005, Par received approval for and introduced the appetite stimulant Megace(R) ES, its first branded pharmaceutical product. Par's Generic Products Division is committed to providing high-quality pharmaceuticals that are affordable and accessible to patients. Par manufactures, markets or licenses more than 110 generic drugs.
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.