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FDA Approves Breckenridge's Generic Activella

Armen Hareyan's picture

Breckenridge Pharmaceutical announced that FDA has granted final approval for Company's 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.

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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.