Drugs

FDA Releases Guidances on Generic Topical Drugs

FDA has released three FDA draft guidances that provide general recommendations for physicochemical and structural (Q3) characterization tests, in vitro release test (IVRT) studies, and in vitro permeation test (IVPT) studies for topical generic drug products. The documents are intended to help sponsors who are submitting ANDAs for liquid-based and other semisolid products applied to the skin. The guidances do not address drug products that are administered via nasal, inhalation, oral, or injection-based routes of administration, or which are transdermal or topical delivery systems (including patches, topical patches, or extended-release films), the agency says.

The following breaks down each guidance:

Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs: The draft provides general recommendations for Q3 characterization tests that can be used 1) to assess whether a proposed generic (test) topical product and its reference standard are the same dosage form (to support a demonstration of pharmaceutical equivalence) and 2) to describe properties of the drug product that may be critical to its performance (to support a demonstration of bioequivalence). FDA says the document does not address Q3 characterization for purposes of product quality control.
In Vitro Release Test (IVRT) Studies for Topical Drug Products Submitted in ANDAs: The document provides general recommendations for IVRT studies comparing a proposed generic (test) topical product and its reference standard for the purpose of supporting a demonstration of bioequivalence. The agency says that once validated, an IVRT study may also be useful in controlling product quality and establishing the acceptability of post-approval manufacturing changes.
In Vitro Permeation Test (IVPT) Studies for Topical Drug Products Submitted in ANDAs: The draft provides general recommendations for IVPT studies comparing a proposed generic (test) topical product and its reference standard to support a demonstration of bioequivalence. An IVPT study may be used to assess the rate and extent to which an active ingredient from a topical product becomes available at or near a site of action in the skin and may be used to characterize and compare the rate and extent of bioavailability for a drug from a test and reference topical product, FDA says.

Additionally, FDA posted a draft guidance entitled Topical Dermatologic Corticosteroids: In Vivo Bioequivalence. The document is intended to assist applicants who submit ANDAs for topical dermatologic corticosteroid products and describes recommendations for in vivo studies to demonstrate the bioequivalence of topical corticosteroids. “FDA revised the guidance to provide clarity for potential ANDA applicants on the appropriate pilot and pivotal studies and other recommendations for pharmacodynamic approach to assess the bioequivalence of topical dermatologic corticosteroids,” the agency says. “In the current version of the draft guidance, FDA has updated recommendations related to vasoconstrictor assay, pilot does duration-response, pivotal vasoconstrictor studies, and the appendices.”

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