Regulatorische Updates

AbbVie’s JAK inhibitor Rinbark (upadacitinib) received positive CHMP recommendations to add severe alopecia areata and non‑segmental vitiligo to its label, expanding its autoimmune portfolio.

The FDA granted approval (ANDA084351) for a 4 mg oral tablet of brompheniramine maleate by IVAX Sub Teva Pharm; the product is currently listed as discontinued.

The FDA approved ANDA080126 on Jan 21 1972 for Everylife's STANOZIDE oral tablets containing 100 mg and 300 mg of isoniazid, both now listed as discontinued.

FDA granted approval for ANDA083089 covering two oral capsule strengths of propoxyphene hydrochloride by Roxane; both products are listed as discontinued.

The FDA granted approval (ANDA077770) for Padagis Israel’s prescription topical ointment containing 0.25% desoximetasone.

Japan’s PMDA has approved the SHINSA companion diagnostic (CDx) to help identify patients eligible for specific therapies, updated June 16, 2026.

Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has released an English translation of its review report for the pharmaceutical product RiHEART, available on its website.