2014

Breckenridge Announces Approval of Generic Activella(R)

    BOCA RATON, Fla., April 18 /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 Novo Nordisk's Activella Tablets
 (Estradiol/Norethindrone Acetate 1.0mg / 0.5mg) Tablets.
 
     Estradiol/Norethindrone Acetate Tablets are AB rated to Activella(R), a
 brand product marketed by Novo Nordisk(R), which is used as a treatment for
 moderate to severe vasomotor symptoms associated with menopause, and as
 prevention for postmenopausal osteoporosis.
 
     The brand product had trailing 12 month sales of $57 million, based on
 industry sales data.
 
     Breckenridge is actively seeking development and marketing alliances
 with domestic and foreign companies for generic and branded
 pharmaceuticals.
 
     Breckenridge products are contract 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., a privately-held pharmaceutical
 marketing research and development company founded in 1983, is
 headquartered in Boca Raton, FL, with offices in Berlin, CT, and Fairfield,
 NJ. Breckenridge markets over 100 products in many therapeutic categories
 to over 100 customers in all classes of trade.
 
     Activella(R) is a registered trademark of Novo Nordisk FemCare AG.
 
     Novo Nordisk(R) is a registered trademark of Novo Nordisk A/S
 Corporation.
 
 
 

SOURCE Breckenridge Pharmaceutical, Inc.

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