FDA approves generic estradiol gel for vasomotor symptoms due to menopause

Key takeaways:

• The generic version of estradiol gel for moderate to severe vasomotor symptoms received FDA approval.
• Estradiol gel, 0.1%, is the generic version of Divigel, an estrogen hormone therapy.

ANI Pharmaceuticals received FDA approval for an abbreviated new drug application for estradiol gel, 0.1%, according to a company press release.

Estradiol gel, 0.1%, is the generic version of the reference-listed drug, Divigel, an estrogen hormone therapy used to treat moderate to severe vasomotor symptoms related to menopause. According to the release, currently the annual U.S. market for the generic version, estradiol gel, 0.1%, is approximately $42.3 million.

“The approval and launch of Estradiol Gel, 0.1%, mark an important milestone for ANI, as this is the first topical gel approved from our R&D and manufacturing site in New Jersey,” Nikhil Lalwani, president and CEO of ANI Pharmaceuticals, said in the release. “This launch further highlights our efforts to bring limited-competition products to market and ensure that our high-quality products are readily accessible to our customers and patients in need.”