Regulatorische Updates

The FDA approved the original ANDA for Alprazolam extended‑release tablets (product numbers 001‑004) on Oct 15 2007, with a labeling supplement approved on Nov 29 2011. All four strengths (0.5 mg, 1 mg, 2 mg, 3 mg) are now listed as discontinued by sponsor PH Health.

The FDA has approved Lupin Pharmaceuticals’ generic levetiracetam tablets in 250 mg, 500 mg, and 750 mg oral strengths under ANDA 078154.

FDA granted approval for ANDA077850, a generic nicotine polacrilex buccal gum (4 mg base) by IVAX Sub Teva Pharms, with labeling supplements approved in 2012 and 2013.

A joint inspection by South Korea’s MFDS and local governments uncovered 30 import stalls illegally selling overseas OTC and psychotropic medicines in traditional markets.

The FDA granted accelerated approval to Revolution Medicines' oral RAS inhibitor daraxonrasib, branded Rasonque, for metastatic pancreatic adenocarcinoma patients with prior therapy, after positive ASCO data.

South Korea's Health Ministry has referred 15 additional hospitals and clinics to police over suspected illegal medical fee refunds, bringing the total under investigation to 33.

South Korea’s MFDS will revise labeling of 38 domperidone products to contraindicate use in patients with chromaffin‑cell tumors due to risk of severe hypertension.

Sandoz received FDA approval for a generic ondansetron hydrochloride injection (preservative‑free) under ANDA 077551, with original and supplemental labeling approvals dating from 2007 to 2015.

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

The FDA has granted approval for ANDA077248, an oral tablet formulation of pilocarpine hydrochloride (5 mg and 7.5 mg) manufactured by Impax Labs and Amneal Pharmaceuticals.

The FDA has approved the injectable drug FLUMAZENIL (application ANDA076955) from Fresenius Kabi USA, available in two IV strengths.

FDA granted approval for Watson Labs' ciprofloxacin hydrochloride ophthalmic solution (ANDA 076673), a prescription eye drop approved in 2005 with a labeling update in 2007.