From rxpgnews.com
FDA GivesTentative Approval for Ondansetron Orally Disintegrating Tablets
By Par Pharmaceutical Companies, Inc.
Jun 18, 2005, 21:07
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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