Medicis Aims to Alter Bioequivalence Requirements for Generic Solodyn

The waiver provisions in the FDA’s draft guidance of bioequivalence requirements for generic versions of Medicis Pharmaceutical’s once-daily oral acne drug would put the public at risk, the company argues in a citizen petition. Medicis is asking the FDA not to approve any generic versions of Solodyn without requiring in vivo bioequivalence testing for each strength of the drug.

Medicis sent the petition to the FDA in response to draft bioequivalence guidelines for Solodyn (minocycline HCl) extended-release tablets posted on the FDA’s website late last year. The draft is part of the agency’s plan to develop a full set of online product-specific bioequivalence recommendations that generic drug applicants can use instead of having to request assistance in bioequivalence study design.

The draft guidelines for generic Solodyn only require in vivo bioequivalence testing for the 135-mg tablets while allowing a waiver for the 45- and 90-mg tablets as long as those strengths are “proportionally similar” to the 135-mg tablets.

But, according to Medicis’ March 20 petition, the 45- and 90-mg strengths of Solodyn are not dose-proportional to the 135-mg strength. The company had believed the various strengths to be proportional, but newer bioequivalence data has shown otherwise, it says. Therefore, it also is asking the FDA to designate the 90-mg Solodyn as a separate reference-listed drug from the 135-mg strength.

The list of draft product-specific bioequivalence guidelines is available at www.fda.gov/cder/guidance/bioequivalence/default.htm. The Medicis petition is available at www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2008-P-0185.