SANTA ANA, Calif., Oct. 5, 2015 /PRNewswire/ -- 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." Damon Jones, Vice President of Operations for MPI, noted, "We are very excited to continue to move HPC to commercial launch and provide patient access to this important product."
MPI's expected commercial launch is 2016.
About McGuff Pharmaceuticals, Inc.
McGuff Pharmaceuticals is a U.S. based FDA registered manufacturer of investigational and commercial sterile drug products. McGuff also has proven expertise in obtaining and maintaining national and international drug approvals.
About McGuff Companies
The McGuff family of companies is veteran owned and privately held. McGuff provides commercial pharmaceuticals, compounded drugs, medical products and contract services used by leading healthcare organizations and professionals.
- McGuff Company, Inc. – Medical Products Distribution Center
- McGuff Pharmaceuticals, Inc. – Commercial drug manufacturing
- McGuff Medical Canada, Inc. – Medical products distribution
- McGuff Compounding Pharmacy Services, Inc. – Pharmacy and Compounded drugs
For more information:
FDA ANDA Approval http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200271Orig1s000ltr.pdf
Hydroxyprogesterone Insert: http://www.mcguffpharmaceuticals.com/images/MD381-0051-Hydroxyprogesterone-Insert%20_v6.pdf
SOURCE McGuff Pharmaceuticals, Inc.