Duramed's Enjuvia gets two FDA appros

Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals, has received two US Food and Drug Administration approvals related to its Enjuvia (synthetic conjugated estrogens, B) product. The FDA has approved the company's supplemental New Drug Application for a 0.9mg tablet strength, which will be added to the existing product line that includes the 0.3mg, 0.45mg, 0.625mg and 1.25mg dosages

In addition, Enjuvia is the first and only oral estrogen that has been approved by the FDA to treat moderate-to-severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause. The product is already indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.