Navigation Links
Current Progress Towards ANDA Approval of Hydroxyprogesterone Caproate Injection, USP
Date:6/19/2013

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

Read the full story at http://www.prweb.com/releases/2013/6/prweb10833717.htm.


'/>"/>
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. Hound.com Finds Jobs in South Atlantic and South West Central Regions Mirroring Current Employment Trends
6. Apple Products are Currently Marked Down at SportsFanPlayground.com
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:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... New York (PRWEB) , ... February 05, 2016 , ... ... use and find themselves having to wait longer to access the treadmills. It’s a ... New Year’s resolutions to lose weight and get in shape by joining gyms, starting ...
(Date:2/5/2016)... ... 2016 , ... Pivot Point Consulting, a leading national Healthcare ... Services for HIT Implementation Support & Staffing report with an outstanding score of ... healthcare executives, managers and clinicians representing over 4,500 hospitals and 2,500 clinics. , ...
(Date:2/5/2016)... , ... February 05, 2016 , ... Stuart Bentkover, ... technology, the PicoSure. Designed to provide the most effective tattoo removal today, Dr. Bentkover ... unmatched results. , Developed by Cynosure, the PicoSure has been approved by the Food ...
(Date:2/5/2016)... Pekin, IL (PRWEB) , ... February 05, 2016 , ... ... in disguised form as a dream. A hallmark feature of patients with eating disorders ... and needs. The eating disorder behaviors and obsessions are regarded as maladaptive means for ...
(Date:2/5/2016)... ... February 05, 2016 , ... On June 9-10, ... a continuing medical education (CME) event presented by the Association for Comprehensive Care ... first for ACCORD, whose mission is to provide education, tools, and resources to ...
Breaking Medicine News(10 mins):
(Date:2/5/2016)... WILLIAMSBURG, Va. , Feb. 5, 2016  ivWatch, a ... a Virginia Outstanding STEM Award granted by Governor Terry ... for Science Innovation on February 25th at an event to ... . The STEM award honors professionals and business that ... Logo - http://photos.prnewswire.com/prnh/20160205/330117LOGO ...
(Date:2/5/2016)... MILTON, Ontario , Feb. 5, 2016  Aralez ... business combination of POZEN Inc. ("POZEN") and Tribute Pharmaceuticals Canada ... of POZEN and shareholders of Tribute. The combined company ... specialty pharmaceutical company with operations in Canada ... the United States . Under the terms ...
(Date:2/5/2016)...  Venice,s newest laser clinic, Physicians Advanced ... kind in the area and specializes in the ... The physician-owned and operated laser clinic is taking ... with its revitalizing skin care approach, unprecedented eVisit ... technology. http://photos.prnewswire.com/prnh/20160204/329957 --> ...
Breaking Medicine Technology: