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pollyvonwog

02/10/14 3:21 PM

#11148 RE: joethdo #11147

All indications say they are close to approving imo. The statement below tells me their stocking up for launch like they did before enox.

The ANDA for M356 is under active review by the U.S. FDA. The company and its collaboration partner, Sandoz, are preparing for the potential launch of this generic in 2014, pending U.S. FDA approval.