FDA GivesTentative Approval for Ondansetron Orally Disintegrating Tablets
Jun 18, 2005 - 9:07:00 PM
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The product is used for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, certain radiotherapies, and the prevention of postoperative nausea and/or vomiting.
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By Par Pharmaceutical Companies, Inc.,
[RxPG] Par Pharmaceutical Companies, Inc. today announced that the the U.S. Food and Drug Administration (FDA) granted tentative approval for the company's Abbreviated New Drug Application (ANDA) for ondansetron hydrochloride (HCl) orally disintegrating tablets (ODT) in 4 mg and 8 mg strengths. GlaxoSmithKline currently markets ondansetron HCl ODT under the brand name Zofran ODT(R). The product is used for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, certain radiotherapies, and the prevention of postoperative nausea and/or vomiting. Annual U.S. sales of Zofran ODT(R) are approximately $225 million.
Par's wholly-owned subsidiary, Kali Laboratories, Inc., filed an ANDA containing a paragraph IV certification with the FDA in September 2002 seeking marketing clearance for its generic version of Zofran ODT(R). In October 2002, Kali's ANDA was accepted for filing by the FDA. Par believes Kali was the first to file and may be entitled up to 180 days of marketing exclusivity for the product.
Kali is currently involved in litigation with GlaxoSmithKline, who has alleged that Kali's product infringes U.S. Patent Nos. 5,578,628 and 4,753,789. Kali has alleged that its product does not infringe any valid claim of these patents and that the patents are invalid and unenforceable. GlaxoSmithKline did not file suit against Kali on U.S. Patent Nos. 5955488 and 6063802.
Under the terms of Kali's agreement with PLIVA, Inc., PLIVA has exclusive rights to market, sell and distribute ondansetron HCl ODT in the U.S. The product will be manufactured by Kali and the companies will split profits from the sales of the product.
A tentative approval reflects the FDA's preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of any patents or exclusivity periods accorded to the reference listed drug. A tentative approval does not allow the applicant to market the generic product and postpones the final approval until all patent/exclusivity issues have expired.
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Additional information about the news article
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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 for specialty markets and expects to introduce the first of these in 2005. Par currently manufactures, markets or licenses more than 85 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.
CONTACT: Stephen J. Mock, or Cecelia C. Heer, both of Par PharmaceuticalCompanies, Inc., +1-201-802-4000
Web site: http://www.parpharm.com/
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