Drugs

Dialyvite 3000 — Hillestad Pharmaceuticals USA drug label update

adapalene and benzoyl peroxide — Glenmark Pharmaceuticals Inc., USA drug label update

FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug

Ultra Violette Sheen Screen Hydrating Lip Balm Last Bite Broad Spectrum SPF 50 — Grace and Fire USA Inc. drug label update

Ultra Violette Sheen Screen Hydrating Lip Balm Silk Pillow Broad Spectrum SPF 50 — Grace and Fire USA Inc. drug label update

FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia

B. Braun Medical, Inc. Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection, 1L, E7500 Due to the Presence of Particulate Matter in Solution

Warning Letter — Lexia LLC: Center for Drug Evaluation and Research (CDER)

Warning Letter — Intas Pharmaceuticals Limited: Center for Drug Evaluation and Research (CDER)

Warning Letter — Foshan Miwei Cosmetics Co., Ltd.: Center for Drug Evaluation and Research (CDER)

Early Alert: Automated Compounding System Issue from Omnicell

Owen Biosciences Inc. — Class II: FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT

Xiamen Kang Zhongyuan Biotechnology Co., Ltd. — Class II: exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drop

SUN PHARMACEUTICAL INDUSTRIES INC — Class II: Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Bram

Xiamen Kang Zhongyuan Biotechnology Co., Ltd. — Class II: MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Le

Xiamen Kang Zhongyuan Biotechnology Co., Ltd. — Class II: MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-coun

Xiamen Kang Zhongyuan Biotechnology Co., Ltd. — Class II: Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-cou

FDA Approves First New Molecular Entity Under National Priority Voucher Program

FDA Approves Drug to Treat Neurologic Manifestations of Hunter Syndrome

FDA Approves Fourth Product Under National Priority Voucher Program, Higher Dose Semaglutide

FDA Releases Draft Guidance on Alternatives to Animal Testing in Drug Development

FDA Approves First Treatment for Patients with Cerebral Folate Transport Deficiency