FDA Issues Draft Guidance on Tentatively Approved ANDAs

The FDA released draft guidance for companies seeking amendments or final approval for tentatively approved ANDAs.

ANDA applicants may submit amendments to tentatively approved applications to propose changes to the application or they may ask for final approval or both. If the proposed amendment is major — a new facility for example — the applicant will need a preapproval inspection, according to the draft.

The agency said it may defer assessments of amendments that are not final approval requests if the earliest lawful final approval date is several years away.