BOCA RATON, Fla., March 27, 2018 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that the U.S. Foodand Drug Administration has granted final approval for its Abbreviated New Drug Application for Entecavir tablets USP, 0.5mg and 1mg, a generic version of BaracludeŽ Tablets by Bristol-Myers Squibb Company. The product, which was developed in collaboration
Entecavir tablets (BaracludeŽ) are a Hepatitis B virus nucleoside analog reverse transciptase inhibitor for the treatment of chronic hepatitis B virus infection in adults and children at least 2 year of age. BaracludeŽ generated combined annual sales of $95.9M, according to MAT January 2018 IQVIA sales data.
About Breckenridge: Breckenridge Pharmaceutical, Inc. is a privately-held own-label distributor that performs pharmaceutical marketing, 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 injectable products. www.bpirx.com
About Welding GmbH & Co. KG: Welding is a privately owned company, headquartered in Hamburg, Germany, with a subsidiary in Lyon, France.
Founded in 1955, Welding tackles the challenges of the global pharma market with fully compliant and comprehensive development solutions for the pharmaceutical industry, including, but not limited to API sourcing, formulation development, registration, regulatory affairs, licensing, launch and supply chain management.
In addition, Welding understands the important role and responsibility that we have as a premier partner in global marketing, sourcing and distribution of active pharmaceutical ingredients. www.welding.eu
*All brand names and trademarks are the property of their respective owners.
View original content:http://www.prnewswire.com/news-releases/breckenridge-pharmaceutical-inc-announces-final-approval-of-its-anda-entecavir-tablets-baraclude-300620205.html
SOURCE Breckenridge Pharmaceutical, Inc.
Subscribe to our Free Newsletters!
Necrotizing fasciitis is a rare life threatening bacterial infection of the tissue below the skin ...
Menstruation or period is the discharge of blood and mucus called menses from the uterus via the ...
Chronic dieting is associated with eating disorders that mainly include unhealthy eating practices ...View All