Drugs

pH Adjuster Waiver Request Guidance

FDA has issued a draft guidance, Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use, describing how the agency intends to evaluate such waiver requests. The document also makes recommendations on the timing and process for requesting the waiver.

“This guidance is intended to assist ANDA applicants that reference a reference-listed drug (RLD) intended for parenteral, ophthalmic, or otic use but are seeking approval of a drug that is qualitatively different or quantitatively different from the RLD with respect to pH adjustment,” FDA says. “This guidance is intended to identify the type of information FDA may generally consider in evaluating a waiver request for pH adjusters in generic drug products intended for parenteral, ophthalmic, or otic use, and provide recommendations to ANDA applicants regarding the submission and content of such a waiver request.”

The recommendations in the guidance are limited to inactive ingredients in ANDAs that adjust the pH of a drug product intended for parenteral, ophthalmic, or otic use, and do not apply to other inactive ingredients.

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