Gulfstream Daily Brief

Regulatory intelligence and policy · Issue 040

FDA opens a famotidine ANDA pathway, EMA consults on three bioequivalence guidances

Today’s official updates cover a new FDA determination supporting potential generic approvals, three EMA bioequivalence consultations, and an MHRA medicines recall.

By Scott Morvay, Founder October 27, 2026 Official sources linked

FDA

FDA clears a regulatory route for generic PEPCID RPD

FDA determined that PEPCID RPD (famotidine) orally disintegrating tablets, 20 mg and 40 mg, were not withdrawn for safety or effectiveness reasons. FDA may approve ANDAs if all other legal and regulatory requirements are met.

Read the official source

EMA

EMA opens consultation on niraparib bioequivalence guidance

EMA published draft product specific bioequivalence guidance for niraparib 100 mg hard capsules and film coated tablets. Consultation is open.

Read the official source

EMA

EMA consults on raltegravir bioequivalence guidance

EMA opened consultation on draft product specific bioequivalence guidance covering raltegravir film coated tablets, chewable tablets, and granules for oral suspension.

Read the official source

EMA

EMA opens consultation on semaglutide tablet bioequivalence guidance

EMA published draft product specific bioequivalence guidance for semaglutide tablets in 1.5, 4, 9, 25, and 50 mg strengths. Consultation is open.

Read the official source

MHRA

MHRA issues Class 2 recall for Xeal Pharma clopidogrel oral liquids

Xeal Pharma informed MHRA that all strengths of its clopidogrel oral suspension and oral solution contain less than the labelled amount of clopidogrel.

Read the official source

MHRA

MHRA highlights Yellow Card reporting for MedSafetyWeek

MHRA announced that MedSafetyWeek will run from 2 to 8 November 2026, promoting reporting of suspected medicine side effects and medical device incidents, alongside updates to the Yellow Card website and app.

Read the official source

Why this matters

The FDA determination defines an avenue for famotidine ANDA review, while EMA’s open consultations give stakeholders an opportunity to examine proposed bioequivalence expectations across several dosage forms. The MHRA updates reinforce the operational importance of product quality oversight and adverse event reporting.

Scott Morvay

Founder, Gulfstream Intelligence

This brief provides general regulatory news and educational information. It is not legal or regulatory advice.