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Entecavir - Final Approval
[Mar 27, 2018]

Breckenridge Pharmaceutical, Inc. Announces Final Approval of its ANDA Entecavir tablets (Baraclude®)

 

Boca Raton, Florida, March 27, 2018 - Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Entecavir tablets USP, 0.5mg and 1mg, a generic version of Baraclude® Tablets by Bristol-Myers Squibb Company.  The product, which was developed in collaboration with Welding GMBH & Co., is manufactured by RA Chem Pharma Limited and supplied to Breckenridge for exclusive distribution in the United States.  Breckenridge will launch the product immediately. 

 

Entecavir tablets (Baraclude®) 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.  Baraclude® 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

 

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