FDA Issues Guide for Generic Cream Chemistry

2026-06379 — Issuance of Priority Review Voucher; Rare Pediatric Disease Product; KRESLADI (marnetegragene autotemcel)

The FDA just gave Rocket Pharmaceuticals a special priority review voucher for their rare pediatric disease treatment, KRESLADI, approved on March 26, 2026. This voucher speeds up future FDA reviews, helping get important medicines to kids with rare diseases faster. It’s a big win for patients, the company, and anyone cheering for quicker cures!

2026-06314 — Determination That INAPSINE (Droperidol) Injection, 2.5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The FDA has decided that INAPSINE (droperidol) injection wasn’t taken off the market because of safety or effectiveness problems. This means generic versions can keep being approved and sold as long as they follow the rules. Patients and healthcare providers can keep trusting this medicine without worry, and drug makers can continue their work without delays or extra costs.

2026-06294 — Consideration of Acceptable Market Name Change for Certain Rockfish (Sebastes spp.); Request for Information

The FDA wants to hear from fishermen, seafood sellers, and fish lovers about possibly changing the official market names for certain rockfish species. This update aims to make fish labels clearer and safer for everyone, with comments open until May 1, 2026. If the name changes happen, it could affect how these fish are sold and marketed, so your input matters!

2026-06316 — Issuance of Priority Review Voucher; Rare Pediatric Disease Product; YUVIWEL (navepegritide)

The FDA just gave Ascendis Pharma a special priority review voucher for their rare pediatric disease drug, YUVIWEL, which helps kids with achondroplasia grow taller. This voucher speeds up future drug reviews and can be a valuable asset, saving time and potentially money. Approved on February 27, 2026, this move highlights the FDA’s commitment to fast-tracking treatments for rare childhood conditions.

2026-06187 — Notice of Decision on a Hearing Request Regarding a Proposal To Refuse To Approve a New Drug Application for TRADIPITANT Capsules

The FDA has decided not to approve Vanda Pharmaceuticals’ new drug, TRADIPITANT capsules, meant to treat symptoms of gastroparesis. Vanda asked for a hearing to challenge this, but the FDA denied it. This means patients and doctors will have to wait longer for this treatment, and Vanda faces delays and extra costs as they figure out their next move.

2026-05913 — Elite Laboratories, Inc., et al.; Withdrawal of Approval of 72 Abbreviated New Drug Applications; Correction

The FDA fixed a mistake about pulling approvals for 72 generic drug applications. One drug, a valproic acid capsule from Upsher-Smith Laboratories, won’t lose its approval because the company asked to keep it. This means the drug stays available, and the change took effect before October 23, 2025.

Previous: 2026-05274 — Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Countermeasures Injury Compensation Program-OMB No. 0915-0334-Revision

HRSA is updating the forms and questions for the Countermeasures Injury Compensation Program to make things easier and clearer for people filing claims. This affects anyone who might get injured by certain medical countermeasures, like vaccines or treatments during emergencies. The public can comment on these changes until April 17, 2026, and no new costs are expected.

Next: 2026-05276 — Over-the-Counter Monograph Drug Facility Fee Rates for Fiscal Year 2026

Starting October 1, 2025, companies that make or submit requests for over-the-counter (OTC) drug products will pay new facility fees for fiscal year 2026. These fees help the FDA keep OTC drugs safe and effective. If you own or run an OTC drug facility, get ready for these updated charges that last through September 30, 2026.