Obesity & Diabetes Week
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Obesity & Diabetes Week
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Generic Diabetes Therapy
IVAX "first to file" for Metformin ER Tablet; FDA grants approval
November 24th, 2003
IVAX Corp. (IVX) received final approval and confirmation of its first-to-file status from the U.S. Food and Drug Adminstration (FDA) on its abbreviated new drug application (ANDA) for Metformin HCl Extended Release (ER).
The generic product will be immediately marketed by the company's wholly owned subsidiary, IVAX Pharmaceuticals, Inc. Metformin ER is the generic equivalent of Glucophage XR, which is marketed by Bristol-Myers Squibb and used for the treatment of type 2 diabetes. U.S. sales for Glucophage XR were over $453 million for the 12 months ending in June 2003.
IVAX's pipeline now consists of 38 ANDAs pending with the FDA of which...
Source: Obesity & Diabetes Week (2003-11-24)
|
|
|
