Par Pharmaceutical Receives Approval for Ondansetron Orally Disintegrating Tablets
Par to Manufacture, Barr Pharmaceuticals Inc.'s PLIVA Subsidiary to Market Product;
Ondansetron ODT Awarded 180 Days' Marketing Exclusivity
WOODCLIFF LAKE, N.J., Dec. 26 (HSMN NewsFeed) -- Par Pharmaceutical Companies, Inc. (NYSE: PRX ) today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for ondansetron orally disintegrating tablets (ODT) in 4 mg and 8 mg strengths. Par has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for the product, which will be marketed by PLIVA, Inc., the U.S. subsidiary of PLIVA d.d., which is a subsidiary of Barr Pharmaceuticals, Inc. of Woodcliff Lake, New Jersey.
Ondansetron ODT is the generic version of GlaxoSmithKline's Zofran ODT®. The product is used for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy and with initial and repeat courses of moderately emetogenic cancer chemotherapy, certain radiotherapies, and the prevention of postoperative nausea and/or vomiting. Annual U.S. sales of Zofran ODT® are approximately $300 million, according to IMS Health.
Under the terms of an agreement between the two companies, Barr will have exclusive rights to market, sell and distribute ondansetron ODT in the U.S. The product will be manufactured by Par, and the companies will split profits from the sales of the product.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic drug and innovative branded pharmaceuticals for specialty markets. 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.
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