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
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.
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
SOURCE Breckenridge Pharmaceutical, Inc.