Navigation Links
Breckenridge Announces Approval of Generic Activella® 0.5mg/0.1mg Tablets

BOCA RATON, Fla., June 10, 2011 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Activella® 0.5mg/0.1mg Tablets. The company currently markets an equivalent to Activella® 1.0mg/0.5mg Tablets, as (Estradiol/Norethindrone Acetate 1.0mg/0.5mg) Tablets.

Estradiol/Norethindrone Acetate Tablets is AB rated to Activella®, a brand product marketed by Novo Nordisk®, which is used as a treatment for moderate to severe vasomotor symptoms associated with menopause, and as prevention for postmenopausal osteoporosis. The original dose strength is also indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause in women who have a uterus.

The brand product had trailing 12 month sales of $28.5 million, based on industry sales data.

Breckenridge products are manufactured through partnerships with pharmaceutical manufacturers in state-of-the-art facilities throughout the world. Breckenridge maintains a stringent Quality Assurance program to ensure a consistent supply of quality pharmaceutical products.

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.

SOURCE Breckenridge Pharmaceutical, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1

Related medicine technology :

1. Breckenridge Announces Approval of Anastrozole Tablets
2. Breckenridge Pharmaceutical to Market Methylphenidate Oral Solution Through Agreement With Tris Pharma (Monmouth Junction, NJ)
3. Breckenridge Pharmaceutical Enters Agreement with Oman Pharmaceutical Products Company LLC
4. Breckenridge Pharmaceutical Announces Settlement of Actos® (Pioglitazone Hydrochloride) Patent Litigation
5. Breckenridge Announces Approval of Letrozole Tablets
6. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
7. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
8. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
9. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
10. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
11. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
Post Your Comments:
(Date:11/25/2015)... THOUSAND OAKS, Calif. , Nov. 25, 2015 /PRNewswire/ ... of a Biologics License Application (BLA) with ... Administration (FDA) for ABP 501, a biosimilar candidate to ... the first adalimumab biosimilar application submitted to the FDA ... biosimilar pathway. Sean E. Harper , M.D., ...
(Date:11/25/2015)... AAIPharma Services Corp./Cambridge Major Laboratories, Inc. ... $15.8  Million to expand its laboratories and global ... The expansion will provide additional office space and ... of the pharmaceutical and biotechnology markets. ... up to 40,000 square feet of expanded development ...
(Date:11/25/2015)... Nov. 25, 2015  Henry Schein, Inc., the world,s ... office-based dental, medical and animal health practitioners, will unveil ... Henry Schein ConnectDental® Pavilion , which brings together ... open solutions designed to help any practice or laboratory ... for a schedule of experts appearing at the ...
Breaking Medicine Technology:
(Date:11/27/2015)... , ... November 27, 2015 , ... CBD College ... of Allied Health Education Programs (CAAHEP) awarded accreditation to its Diagnostic Medical Sonography program. ... accredited colleges, as only one of twelve colleges and universities in the state of ...
(Date:11/27/2015)... ... November 27, 2015 , ... Avid collector, Andrew Hawley from Vintage Rock Posters, ... posters. This is one of Joplin's most famous and beautiful concert posters. The concert ... Michigan in Ann Arbor. The According to Hawley, "It is hard to believe that ...
(Date:11/26/2015)... ... 26, 2015 , ... Inevitably when people think Thanksgiving, they also think Holiday ... the Black Friday and Cyber Monday massage chair sales to receive the ... and low to find the best massage chair deals, they can see all of ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... to discuss bioavailability and the need to integrate dose form selection in early ... with OBN, the membership organization supporting and bringing together the UK’s emerging life ...
(Date:11/26/2015)... ... November 26, 2015 , ... WorldCare International, Inc., the ... 61st annual Employee Benefits Conference. The Employee Benefits Conference was hosted by the ... Wednesday, November 11th, 2015. The conference was held at the Hawaii Convention Center ...
Breaking Medicine News(10 mins):