WOODCLIFF LAKE, N.J., Jan. 3, 2011 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that it began shipping all strengths of amlodipine besylate and benazepril hydrochloride capsules, the generic version of Novartis’ Lotrel®. Par has been awarded 180 days of marketing exclusivity for the 5/320mg and 10/320mg strengths, commencing at launch, for being the first to file an ANDA containing a paragraph IV certification for the product. According to IMS Health data, annual sales in the U.S. for these two strengths of Lotrel are approximately $361 million.
Important information about amlodipine besylate and benazepril hydrochloride capsules
Amlodipine besylate and benazepril hydrochloride capsules are a combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and benazepril, an angiotension converting enzyme (ACE) inhibitor. Amlodipine besylate and benazepril hydrochloride tablets are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
Amlodipine besylate and benazepril hydrochloride capsules are contraindicated in patients with a history of angioedema, with or without previous ACE inhibitor treatment, or patients who are hypersensitive to benazepril, to any other ACE inhibitor, or to amlodipine.
When pregnancy is detected, amlodipine besylate and benazepril hydrochloride capsules should be discontinued as soon as possible. Drugs that act directly on the rennin-angiotension system can cause injury and death to the developing fetus. Refer to full prescribing information for complete boxed WARNING.
About Par Pharmaceutical Companies, Inc.
Par Pharmaceutical Companies, Inc. is a U.S.-based specialty pharmaceutical company. Through its wholly-owned subsidiary’s two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets higher-barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals. For press releases and other company information, visit www.parpharm.com.
Safe Harbor Statement
Certain statements in this news 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, as such, are subject to known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company’s most recent Annual Report on Form 10-K, in other of the Company’s filings with the SEC from time to time, including Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and on general industry and economic conditions. Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.
SOURCE Par Pharmaceutical Companies, Inc.
