Mylan receives FDA approval for Ondansetron tablets

Jun 26 2007

Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Applications (ANDAs) for Ondansetron Hydrochloride (HCl) Tablets, 4 mg (base), 8 mg (base) and 24 mg (base), and Ondansetron Orally Disintegrating Tablets (ODT) USP, 4 mg and 8 mg.

Ondansetron HCl Tablets are the generic version of GlaxoSmithKline's Zofran(R) Tablets. Ondansetron HCl Tablets had U.S. sales of approximately $744 million for the same strengths for the 12-month period ending March 31, 2007, according to IMS Health.

Ondansetron ODT are the generic version of GlaxoSmithKline's Zofran ODT(R) Tablets. Ondansetron ODT had U.S. sales of approximately $348 million for the same strengths for the 12-month period ending March 31, 2007, according to IMS Health.

These products will be shipped immediately.