Navigation Links
Current Progress Towards ANDA Approval of Hydroxyprogesterone Caproate Injection, USP

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

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


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

Read the full story at

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1. PET/MR effective for imaging recurrent prostate cancer
2. ENT and Allergy Associates®, LLP Is Bullish on Wall Street; Practice to Expand/Upgrade Current Clinical Office at 150 Broadway in NYC
3. Verndale Launches Current Digital, a Technology Partner for Ad and Creative Agencies
4. Poliovirus vaccine trial shows early promise for recurrent glioblastoma
5. Finds Jobs in South Atlantic and South West Central Regions Mirroring Current Employment Trends
6. Apple Products are Currently Marked Down at
7. Seeking Damages From Bullies: New Website, Bullying Decoded, Reviews Current Legal Cases and Statutes
8. Minimal dose CT superior to chest X-ray for detection of recurrent lung cancer
9. Study reports adenoma detection rates are higher than current guidelines suggest in both men and women
10. Current HPV vaccine may not help some women with immune problems
11. Global burden of dengue is triple current estimates
Post Your Comments:
(Date:10/12/2015)... ... 2015 , ... FEI Behavioral Health, a social enterprise with ... management, will present a session at the Wisconsin Society for Human Resource Management ... Chief Operating Officer Daniel Potterton will present an informative workshop, “Training HR to ...
(Date:10/12/2015)... ... October 12, 2015 , ... ... part of a contact channel benchmarking study. Be a part of ... operational strategies for improving customer experience, customer journey, contact channel execution and intelligence, ...
(Date:10/12/2015)... DC (PRWEB) , ... October 12, 2015 , ... ... been selected to receive a Eugene Washington Engagement Award by the Patient-Centered Outcomes ... more effectively with the research community. , The project, entitled “Training Patients ...
(Date:10/12/2015)... ... 12, 2015 , ... The translation for ARIS® 7.x and 9.x to Microsoft ... installations into the Microsoft world. The ARIS models will be fully translated and mapped ... for both IT and Office users it is acknowledged as a competitive alternative to ...
(Date:10/12/2015)... ... October 12, 2015 , ... METTLER TOLEDO is ... processes. In addition, METTLER TOLEDO has collaborated with manufacturing consultant and lean laboratory ... help improve productivity through the identification and elimination of 'hidden' time-wasting activities. Mr ...
Breaking Medicine News(10 mins):
(Date:10/12/2015)... This study focuses on China,s Genome-Based ... decades, the industry has been growing at a fast pace. ... consumptions in China have transformed ... is one of the world,s major producers for ... world, China is the world,s fastest ...
(Date:10/12/2015)... -- About epilepsy --> ... disorders manifested by benign to severe, disabling, and life-threatening ... malformations and tumors to meningitis, high-risk pregnancies, and trauma ... is unidentified, as is witnessed in the majority of ... between the inhibitory and excitatory signals of the brain, ...
(Date:10/12/2015)... Oct. 12, 2015 A new computer program ... can predict whether they will develop effective language skills ... a study in the journal Brain and Behavior ... In the journal,s Oct. 12 online edition, researchers ... program determines how specific regions of the brain respond ...
Breaking Medicine Technology: