You are here

Generic Version of Glucophage Approved by FDA

PITTSBURGH, Sept. 14 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE:MYL) today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Metformin Hydrochloride Extended-release Tablets, 500 mg and 750 mg. Metformin HCl ER Tablets, which are the generic version of Bristol-Myers Squibb's Glucophage(R) XR Tablets, 500 mg and 750 mg, had U.S. sales of approximately $173 million, for the 12-month period ending June 30, 2005, according to IMS.

This product will be available soon.

Source: Mylan Laboratories Inc.

Recent Headlines

Breast Cancer, Gastrointestinal Tumors Most Common Types
Two-Thirds of U.S. Alzheimer’s Cases Are Women, And It’s Not Just Because They Live Longer
Recarbrio Should be Reserved For Limited/No Alternative Antibacterial Treatment Cases
NY Hospitals Required to Implement Protocols in Suspected Cases
Presence of BOK Protein Key for Positive Treatment Response
Patient Access to Inhaler Use Data Could Improve Asthma Management
Overall Survival 4.3 Months’ vs. 1.5 Months for Traditional Regimens