Barr metformin tentative ANDA revoked
Executive Summary
FDA withdraws Barr's tentative approval for metformin extended-release (Bristol-Myers Squibb's Glucophage XR) because of concerns with raw material supplied by Ivax-owned API (formerly ChemSource). Barr expects to select a new raw materials supplier. Ivax markets generic metformin under 180-day exclusivity, splitting profits with Purepac (1"The Pink Sheet" Dec. 1, 2003, p. 17). Par is also on the market with an "authorized" metformin generic...
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