Actualités réglementaires

The FDA approved ANDA077302 for Actavis Pharma’s oral extended‑release capsules containing dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate in multiple strengths.

The FDA has approved application ANDA077013 for pravastatin sodium tablets (10‑80 mg) from sponsor Pharmobedient; all listed product numbers are marked discontinued.

FDA approved three manufacturing supplement submissions for Isoniazid tablets (50 mg and 100 mg) under ANDA080132; both products are listed as discontinued.

The FDA has approved ANDA211623 for carbamazepine extended‑release tablets (100 mg, 200 mg, 400 mg) submitted by Unique Pharm, with labeling cleared in Jan 2024.

The FDA record for ANDA 084217 lists two discontinued oral chlorothiazide tablets (500 mg and 250 mg) and a series of approved supplemental submissions covering manufacturing, labeling and bioequivalence.

The FDA has approved ANDA077345 submitted by Heritage Pharma Avet for oral sertraline hydrochloride tablets in 25 mg, 50 mg and 100 mg strengths. All listed products are currently marked discontinued.

The FDA approved ANDA 079021 for atomoxetine hydrochloride capsules from Strides Pharma Science, covering strengths from 10 mg to 100 mg.

The FDA has granted approval for Zydus Lifesciences’ generic leflunomide tablets (10 mg and 20 mg) under ANDA212308.

Korea's Ministry of Health and Welfare unveils a designation system granting generic price incentives to semi‑innovative pharma companies that meet R&D investment thresholds, excluding violations older than five years.

FDA granted approval for Cipla's ANDA078003 generic esomeprazole magnesium, covering two discontinued oral capsule products.

The FDA issued a standard review tentative approval (TA) for ANDA205757 submitted by Pharmascience Inc., status dated Feb 15, 2019.

The PMDA and Toyama Prefecture hosted a symposium celebrating the Hokuriku Branch’s 10th anniversary, highlighting regulatory training and collaboration across Asia.