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®, a brand product marketed by Novo Nordisk®, 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® is a registered trademark of Novo Nordisk FemCare AG.
Novo Nordisk® is a registered trademark of Novo Nordisk A/S Corporation.
Source: Breckenridge Pharmaceutical, Inc.
