BOCA RATON, Fla., June 10, 2011 /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 Activella® 0.5mg/0.1mg Tablets. The company currently markets an equivalent to Activella® 1.0mg/0.5mg Tablets, as (Estradiol/Norethindrone Acetate 1.0mg/0.5mg) Tablets.
Estradiol/Norethindrone Acetate Tablets is 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 original dose strength is also indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause in women who have a uterus.
The brand product had trailing 12 month sales of $28.5 million, based on industry sales data.
Breckenridge products are 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. is a privately-held pharmaceutical marketing, research and development company founded in 1983 that 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, and Powders. www.bpirx.com
SOURCE Breckenridge Pharmaceutical, Inc.