FDA final guidance on generic ophthalmic drug waiver requests

The US Food and Drug Administration (FDA) published the final guidance for industry, “Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.”

This aims to help applicants prepare an abbreviated new drug application (ANDA) that references a reference listed drug (RLD) intended for parenteral, ophthalmic, or otic use but seeks approval of a drug that is qualitatively (Q1) different or quantitatively (Q2) different from the RLD with respect to a pH adjuster(s).

The agency says that, by providing clear information to ANDA applicants and enabling flexibility in how they meet the statutory standards for approval, this guidance will generate cost savings by reducing duplicative efforts, regulatory delays, reformulation costs, and process uncertainties for industry, as well as time spent by FDA reviewing applications.