McGuff Pharmaceutcals, Inc.

Our Mission is to retain
our uncompromising passion for quality pharmaceuticals and customer satisfaction. Pharmaceutical Manufacturing

– Ronald McGuff

News Release

Current Progress Towards ANDA Approval of Hydroxyprogesterone Caproate Injection, USP

FOR IMMEDIATE RELEASE: Thursday, June 13, 2013 5:01pm (PDT)

Dateline:
Santa Ana, CA

SANTA ANA, CA (06/13/2013) -- McGuff Pharmaceuticals, Inc. continues to pursue the approval of an Abbreviated New Drug Application (ANDA) for Hydroxyprogesterone Caproate Injection, USP 250mg/mL, 5mL, multiple dose vial; a generic version of Bristol-Myers Squibb's drug formerly known as Delalutin™. We are providing this update in response to varied inquiries regarding the anticipated approval and market introduction dates for McGuff's Hydroxyprogesterone Caproate Injection, USP drug product.

Regarding the status of our pending ANDA, to date, McGuff has responded to all Food and Drug Administration (FDA) inquiries concerning the ANDA submitted in October 2009. While we are hopeful that a final decision will be made soon, McGuff can not predict when the Agency will make it's final determination concerning the ANDA approval. We remain committed to bringing Hydroxyprogesterone Caproate Injection, USP to market as quickly as possible.

Our commitment to bring cost effective branded and generic injectable drugs to the U.S. and International markets, for the benefit of patients in need, continues to be one of our driving principles.

If you would like more information about this topic or to schedule an interview with Damon P. Jones, Vice President of McGuff Pharmaceuticals, Inc., please contact Maureen French at 800-603-4795 x301 or email mfrench@mcguff.com. You may also visit our website at www.mcguffpharmaceuticals.com.

About McGuff Pharmaceuticals, Inc.

McGuff Pharmaceuticals is a Food and Drug Administration (FDA) inspected sterile fill manufacturer that maintains a tradition of quality and core competency in both FDA current Good Manufacturing Practices (cGMP) and International Organization for Standardization's Quality Management Systems (ISO) 9001:2008, a unique combination for any pharmaceutical manufacturer.

The McGuff family of companies provides commercial pharmaceuticals, compounded drugs, nutritional supplements, medical products and contract services used by leading healthcare organizations and professionals.

The McGuff family of companies includes:

McGuff Company, Inc. – Corporate Headquarters and Medical Products Distribution Center

Subsidiaries:

  • McGuff Pharmaceuticals, Inc. – Commercial drug manufacturing
  • McGuff Medical Canada, Inc. – Medical products distribution
  • McGuff Compounding Pharmacy Services, Inc. – Pharmacy and Compounded drugs

Contact:

McGuff Pharmaceuticals, Inc.
Media Contact: Maureen French
800-603-4795 x301 (office)
mfrench@mcguff.com