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BOCA RATON, Fla. — Breckenridge Pharmaceutical Inc. has received Food and Drug Administration approval for letrozole 2.5 mg tablets and estradiol/norethindrone acetate 0.5mg/0.1mg tablets.
Breckenridge said its letrozole product, which is being supplied under a licensing agreement, are AB-rated to Femara, a $700 million dollar oncology drug marketed by Novartis as a treatment for breast cancer in postmenopausal women.
Meanwhile, Breckenridge said its estradiol/norethindrone acetate 0.5mg/0.1mg tablets are a generic version of Novo Nordisk’s Activella 0.5mg/0.1mg Tablets. Breckenridge already markets an equivalent to Activella 1.0mg/0.5mg tablets as estradiol/norethindrone acetate 1.0mg/0.5mg tablets, 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 related to menopause in women who have a uterus, according to the company.
Breckenridge reported that the branded product had trailing 12-month sales of $28.5 million, based on industry sales data.
