Navigation Links
Breckenridge Announces Approval for Pioglitazone Hydrochloride tablets

BOCA RATON, Fla., Feb. 13, 2013 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today the immediate launch of Pioglitazone Hydrochloride Tablets. The U.S. Food and Drug Administration granted final approval for the Abbreviated New Drug Application (ANDA), which is being manufactured and supplied by Synthon Pharmaceuticals, Inc., and will be available in 15 mg, 30 mg, and 45 mg strengths.  Breckenridge is launching its ANDA prior to patent expiration pursuant to a settlement of Paragraph IV patent litigation with Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America, Inc., who granted Breckenridge and Synthon a license to applicable patents to sell and distribute its ANDA.  Pioglitazone Hydrochloride is AB rated to Actos® a once-daily oral prescription medication that, with diet and exercise, has been shown to be effective for the treatment of type 2 diabetes, and is marketed by Takeda Pharmaceutical. According to industry data, Actos® had approximately $3.7 billion in brand sales for the twelve months ending August 2012, prior to generic competition.  * Actos® is a registered trademark of Takeda Chemical Industries, Ltd.

About Breckenridge:
Breckenridge Pharmaceutical, Inc. is a privately-held pharmaceutical marketing, research and development company founded in 1983 that markets a broad range of generic prescription products in many therapeutic categories.  The Breckenridge label is recognized by Wholesalers, Distributors, Chains, and Managed Care Accounts, as well as Retail Pharmacies nationwide.  The company markets over 70 products in a variety of dosage forms including:  Tablets, Capsules, Soft Gel Capsules, Liquids, Suspensions, and Powders.  

About Synthon:
Synthon Pharmaceuticals, Inc., with its U.S. headquarters and laboratories located in Research Triangle Park, North Carolina, markets generic drugs through partnerships with other leading pharmaceutical companies. Synthon currently holds several approved, or tentatively approved, drug applications and has a pipeline containing more than a dozen products that are expected to be filed with the FDA within the next few years. Synthon Pharmaceuticals, Inc. is part of the Synthon group, a global privately held specialty pharma company with offices, laboratories and manufacturing sites in 11 countries worldwide.

SOURCE Breckenridge Pharmaceutical, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Regulus Announces Timing for Fourth Quarter and Year-End 2012 Financial Results Webcast and Conference Call
2. CryoLife Announces Quarterly Cash Dividend for the First Quarter 2013
3. Xenon Announces Appointment of EVP, Research & Development
4. BiOptix announces expansion of Innovators Program at Molecular Med TRI-CON 2013
5. OncoGenex Announces Plans for the Initiation of the Borealis-2 Clinical Trial Evaluating OGX-427 in Combination with Second-Line Therapy for Bladder Cancer
6. OrbusNeich Announces Favorable Ruling From the European Patent Office
7. Trovagene Announces Commercial Launch Timelines for HPV Carrier and Oncogene Mutation Tests
8. Comprehensive Care Corporation Announces New Medicare Contract with Humana Health Plan of California, Inc.
9. Unilife Corporation Announces Financial Results For Fiscal Year 2013 Second Quarter
10. Regeneron Announces Receipt of Hart-Scott-Rodino Notice
11. DelMar Pharmaceuticals Announces $1.0 Million Third Closing in Private Placement
Post Your Comments:
(Date:6/26/2016)... 2016 Jazz Pharmaceuticals plc (Nasdaq: ... Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ("HSR"), ... Inc. ("Celator"; Nasdaq: CPXX ) expired effective ... As previously announced on May 31, 2016, ... agreement under which Jazz Pharmaceuticals has commenced a tender ...
(Date:6/24/2016)... N.J. , June 24, 2016  Collagen ... the design, development and manufacturing of collagen and ... regeneration announced today that Bill Messer ... and Marketing to further leverage the growing portfolio ... medical devices. Bill joins the Collagen ...
(Date:6/24/2016)... Research and Markets has ... 2015-2025: Applications, Technologies, Forecasts" report to their ... Electronics, Smart Skin, Structural Health Monitoring, Composite Smart ... electronics involves electronic and/or electrical components and circuits ... structures such as vehicle bodies or conformally placed ...
Breaking Medicine Technology:
(Date:6/27/2016)... (PRWEB) , ... June 27, 2016 , ... recently ... of Eyeglasses . , Millions of individuals in the United States and Canada ... become a way to both correct vision and make a fashion statement. Even celebrities ...
(Date:6/26/2016)... ... 26, 2016 , ... On June 10-11, 2016, A Forever Recovery, a holistic ... World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is located. ... some of the world’s leading providers of cereal and other breakfast foods. Its residents ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements owned ... developed to enhance the health of felines. The formula is all-natural and is made ... in the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root ...
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... ... fertility once they have been diagnosed with endometriosis. These women need a treatment ... also require a comprehensive approach that can help for preservation of fertility and ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Austin residents seeking ... American College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical ... effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by ...
Breaking Medicine News(10 mins):