Drugs

CDER Denies Bausch Petition on Duobrii ANDAs

CDER has denied a 2021 citizen petition from Bausch Health that urged FDA not to approve any ANDA that cites Duobrii as the reference-listed drug unless the application meets all the specifications sought by the company. DuobriI (halobetasol propionate and tazarotene) lotion is a topical drug to treat adults with plaque psoriasis. The petition asked that the agency require, at a minimum, that all of the bioequivalence and pharmaceutical equivalence criteria in the document be satisfied for approval of an ANDA for a generic Duobrii. The criteria sought were:

Q1, Q2, and Q3 sameness of inactive ingredients;
Corroboration by clinical endpoint bioequivalence study; and
Successful HPA-axis suppression study.

In denying the petition, CDER disagreed that Q1, Q2, and Q3 sameness is required to demonstrate that a proposed generic drug product is bioequivalent to Duobrii. “It is well understood that differences in formulation, including qualitative and quantitative differences in inactive ingredients, can lead to physicochemical and structural (Q3) differences that could, in turn, lead to differences in performance,” the denial letter said. “These considerations are not unique to Duobrii and have been extensively evaluated within the scope of the Generic Drug User Fee Amendments regulatory science and research program.”

Additionally, CDER said the petition provided “exceedingly weak support for imposing a stricter standard than what is required by regulation by preemptively eliminating generic applicants’ option to demonstrate proposed formulation differences do not affect safety or efficacy… The data presented, however, do not establish that any difference in inactive ingredients (or manufacturing processes) as compared to Duobrii necessarily enhances the risk of bioinequivalence.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome