FDA Approves Generic Diabetes Medication Manufactured by Ivax
Officials for Miami-based generic drug manufacturer Ivax announced Tuesday that the FDA has granted the company final approval to market a generic version of the diabetes drug Glucophage XR, the Miami Herald reports. Ivax received "first-to-file status," meaning that the company has 180 days during which its version will be the only generic version of Glucophage XR -- which is manufactured by Bristol-Myers Squibb and has annual U.S. sales of $453 million -- on the market. Ivax officials said that the company would immediately begin marketing the generic drug under the name Metformin HCI Extended Release. Neil Flanzraich, president of Ivax, said that sales of Metformin HCI Extended Release are projected to "significantly contribute to Ivax's earnings for the fourth quarter of 2003 and beyond." According to the Herald, Ivax currently has 38 applications for approval of its generic drugs pending, nine of which are potentially first-to-file submission on drugs with more than $13 billion in U.S. sales (Dorschner, Miami Herald, 10/29).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.