Current Progress Towards ANDA Approval of Hydroxyprogesterone Caproate Injection, USP

McGuff Pharmaceuticals, Inc. (MPI) 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™. While McGuff Pharmaceuticals can not predict when the FDA will complete its review, MPI remains committed to bringing the drug product to market as quickly as possible.

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McGuff Pharmaceuticals, Inc.
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.

Santa Ana, CA (PRWEB) June 19, 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 fomerly 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(at)mcguff(dot)com. You may also visit our website at http://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


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