Par Pharmaceutical (PRX) Receives Final FDA Approval for Ondansetron ODT
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Par Pharmaceutical Companies, Inc. (NYSE: PRX) 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. (NYSE: BRL) of Woodcliff Lake, New Jersey.
Ondansetron ODT is the generic version of GlaxoSmithKline's (NYSE: GSK) Zofran ODT. The product is used for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy. Annual U.S. sales of Zofran ODT(R) 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.
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