USA – FDA offers guidance on waiver requests for pH adjusters

The US Food and Drug Administration (FDA) has issued a draft guidance on its criteria for permitting the use of pH adjusters in parenteral, ophthalmic or otic abbreviated new drug applications (ANDAs). FDA said in certain circumstances, certain differences in pH adjusters “may be scientifically appropriate and acceptable.”

This guidance outlines the process for requesting a waiver from complying with the generic drug regulations under §314.94(a)(9)(iii) and (iv). These regulations specify that a drug product intended for parenteral, ophthalmic, or otic use generally “must contain the same inactive ingredients and in the same concentration as the reference listed drug identified by the applicant.”

Since these regulations have been issued, the agency has evolved its thinking on pH adjusters, which are considered excipients…