Hydroxyprogesterone Caproate Injection, USP

McGuff Pharmaceuticals, Inc. (MPI), a California based pharmaceutical manufacturer has received an approval from the U.S. Food and Drug Administration (FDA) for an abbreviated new drug application (ANDA) for Hydroxyprogesterone Caproate Injection USP, 250 mg/mL (1.25 g/5 mL vials).

The FDA has determined MPI’s Hydroxyprogesterone Caproate Injection USP, 250 mg/ mL (1.25 g/5 mL vials) to be bioequivalent and, therefore, therapeutically equivalent to Delalutin Injection, 250 mg/mL formerly produced by Bristol Myers Squibb. MPI’s Hydroxyprogesterone Caproate Injection is the current reference listed drug (RLD) for Hydroxyprogesterone Caproate Injection USP, 250 mg/ mL.

Ronald M. McGuff, President and CEO of the Company, commented "This goal was achieved in-house by multidisciplinary teams. I appreciate and thank each employee for their hard work, dedication and diligence to achieve this significant goal. HPC represents our first U.S. generic approval in a pipeline that includes generic and new drug products." Moving HPC to a commercial launch and providing patients access to this important product is a significant accomplishment the organization is proud of.