Synovics Pharmaceuticals, Inc. (OTCBB: SYVC)’s metformin Extended Release (XR) Tablets 500mg has been approved by the USFDA, whose therapeutically equivalent listed drug is Bristol-Myers Squibb Company (BMY)’s Glucophage® XR Extended-Release Tablets 500mg (a pdf file).
Metformin, a member of the biguanide drug class represents the current standard of care for type 2 diabetes management. This approval is Synovics Pharmaceuticals, Inc.’s very first OCR generic drug approval.
"This is a very significant milestone for our Company as it signifies our first OCR generic drug approval and proves our ability to successfully move drugs through the regulatory process," said Ronald H. Lane, Ph.D., Synovics Chairman and Chief Executive Officer.
"The approval of our first generic drug is an affirmation of the utility of our patented technology. Additionally, our generic metformin formulation allows for efficient manufacturing with potential cost advantages over the competition," said Nirmal Mulye, Ph.D., Synovics Chief Scientific Officer.
Synovics Pharmaceuticals, Inc. was formerly known as Bionutrics, Inc.
More details from the press release via PharmLive.
Comment Preview