Draft Guidance Calls for Two Bioequivalence Studies for Progesterone
Generic drugmakers should conduct two studies to show bioequivalence of a test product to its reference product to support ANDAs for infertility treatment progesterone gel, the FDA says.
The agency issued draft guidance in response to a 2013 citizen petition from Watson Laboratories that asked the FDA to require generic applicants to demonstrate bioequivalence to reference product Crinone (progesterone gel), with studies that include pharmacokinetic and clinical endpoints.
The FDA’s recommendations for study design are similar to suggestions proposed by Watson in its petition.
Comments are due by Jan. 1, 2016. The draft guidance Bioequivalence Recommendations for Progesterone is available here: www.fdanews.com/10-15-FDA-BE-Draft.pdf. Read the citizen petition here: www.fdanews.com/10-15-BE-Petition.pdf.