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Azacitidine Approval
[Jun 26, 2017]

June 26, 2017.West Caldwell, NJ 07006 Contact us at


Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval

for Azacitidine for Injection (Vidaza®)


Boca Raton, Florida, June 26, 2017 - 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.

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