Le Lézard
Classified in: Health
Subject: FDA

Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval for Azacitidine for Injection (Vidaza®)



BOCA RATON, Fla., June 26, 2017 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced that FDA has granted final approval of its ANDA Azacitidine for Injection, 100mg per vial, Single-Dose Vial, a generic version of Vidaza® by Celgene Corporation.   Breckenridge submitted the ANDA with its development and manufacturing partner Natco Pharma Limited.  Breckenridge and Natco intend to launch its ANDA in the near future.

Vidaza® is a prescription anti-cancer chemotherapy drug that is indicated to treat myelodysplastic syndrome (MDS). Vidaza® generated total combined sales of $188 million for the twelve-month period ending April, 2017, based on industry sales data.

About Breckenridge:
Breckenridge Pharmaceutical, Inc. is a privately-held own label Distributor that performs pharmaceutical research and development as well as marketing and distribution in the U.S. The company was founded in 1983 and 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, ophthalmics, nasal sprays, powders and injectables, with 39 Paragraph IV challenges filed to date. www.bpirx.com

Vidaza® is a trademark of Celgene Corporation or its affiliates.

 

SOURCE Breckenridge Pharmaceutical, Inc.


These press releases may also interest you

at 13:00
LAGUNA NIGUEL, Calif., Oct. 22, 2017 /PRNewswire/ -- The management team of Crestavilla, a luxury senior living community currently under construction in Laguna Niguel, Calif., has launched a Halloween costume drive to benefit the boys and girls who...

at 06:00
OTTAWA, Oct. 20, 2017 /CNW/ - The Honourable Ginette Petitpas Taylor, Minister of Health, will deliver remarks at the Kid Food Nation Gala and present awards to the winners of the national recipe contest. The Minister will be available to answer...

at 05:23
LONDON, October 22, 2017 /PRNewswire/ -- ? The Dermalex skincare survey indicates that as much as  50% of the GB adult population have suffered with skin conditions in their life ? 64% have had eczema, psoriasis, rosacea or acne for over a decade...

at 02:00
PHILADELPHIA, Oct. 22, 2017 /PRNewswire-USNewswire/ -- Today, Abby and Erin Delaney are able to sit independently from one another, be held separately in their mother and father's arms, and can practice rolling over and crawling. Such everyday...

21 oct 2017
VANCOUVER, Oct. 21, 2017 /CNW/ - For many Canadians, experiencing trauma has a major impact on their lives and plays a role in their problematic substance use. Sex and gender are also important factors in understanding and treating individuals for...

21 oct 2017
VANCOUVER, Oct. 20, 2017 /CNW/ - The Honourable Ginette Petitpas Taylor, Federal Minister of Health, will announce additional support for the BC Centre of Excellence for Women's Health through Health Canada's Substance Use and Addictions Program to...




News published on 26 june 2017 at 12:01 and distributed by: