TherapeuticsMD Wants Imvexxy ANDA Restrictions

TherapeuticsMD is petitioning FDA to not receive or approve any marketing application that references its Imvexxy (estradiol vaginal inserts) unless the application is submitted as a 505(j) ANDA and the ANDA product is manufactured qualitatively the same as Imvexxy, including the teardrop shape. Alternatively, the petition says, the generic application should be submitted as a 505(b)(2). The company also asks that FDA issue product-specific guidance with its proposed requirements.

The petition lists product characteristics that affect the absorption characteristics, amount of estradiol available to be absorbed, and the ability of a woman to correctly place the Imvexxy insert following the product’s instructions for use.

“Because Imvexxy does not show systemic absorption,” the petition says, “these quality attributes are germane to FDA’s review of a generic because pharmacokinetics is not an adequate surrogate to establish bioequivalency to Imvexxy.”