The US regulator approved an additional 0.9mg dose strength tablet, which will be added to the Company’s existing Enjuvia product line that includes the 0.3mg, 0.45mg, 0.625mg, and 1.25mg tablet dosage strengths.
In addition, Enjuvia is also the first and only oral estrogen that has been approved by FDA to treat moderate-to-severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause. Enjuvia is already indicated for the treatment of moderate-to- severe vasomotor symptoms associated with menopause.
Bruce Downey, Barr’s chairman and CEO, said: “The approval of the additional indication for Enjuvia provides female healthcare providers with yet another option for addressing symptoms associated with menopause and may make Enjuvia an appropriate therapeutic option for a larger group of menopausal patients.”
The company plans to launch the Enjuvia 0.9mg tablet and the new indication in October 2007.