FY 2024 GDUFA Science and Research Report

 FDA’s generic drug Science and Research Program, created under the Generic Drug User Fee Amendments (GDUFA), is an essential component of FDA’s mission to protect and promote public health. The Science and Research Program is implemented through extensive research...

Guidances & Reports

The research studies conducted under the Generic Drug User Fee Amendments (GDUFA) initiatives support development of general and product-specific guidances for industry to efficiently develop new generic products. FDA’s Office of Generic Drugs also publishes an...

Brassica Pharma Pvt. Ltd. – 679005

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Uday Chile Brassica Pharma Pvt. Ltd. 301, Soni Palace, Haridas NagarNear Hero Honda ShowroomBorivali (West) 400092India Issuing Office: Center for Drug Evaluation and Research (CDER)...

V10Suppliers.com – 685496 – 07/22/2024

Recipient: V10Suppliers.com United Kingdom Issuing Office: Center for Drug Evaluation and Research (CDER) United States FROM: The United States Food and Drug Administration RE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over...

Yahon Enterprise Co., Ltd. – 675592

Delivery Method: VIA EMAIL WITH READ RECEIPT Product: Drugs Recipient: Recipient Name Mr. Hsu Ke Fu Recipient Title Factory Manager Yahon Enterprise Co., Ltd. An Chu Hamlet, Tay Lac VillageBac Son CommuneTrang Bom District76000Vietnam jacky@yaho.com.vn Issuing Office:...

Advisory Letters

02/19/2025HellCoverX LLC dba Lignosus®lignosus.com, lignosusofficial.com Lignosus® 11/06/2024NavaFresh, Nava Global LLC, Handelnine Global LLCnavafresh.comAddiction Free Plus Powder, HAILONN ANTI ADDICTION DROPS, ZERO Addiction DROP, GOLD-YEAR PLUS Tablets, DIACURE...

Health Fixer Issues Voluntary Nationwide Recall of Male Ultra, Malextra, Electro Buzz, Ultra Armor and Male Ultra Pro Due to Undeclared Chloropretadalafil, Propoxyphenylsildenafil and Sildenafil

Summary Company Announcement Date: April 25, 2025 FDA Publish Date: April 29, 2025 Product Type: Dietary Supplements Reason for Announcement: Recall Reason Description Undeclared Chloropretadalafil, Propoxyphenylsildenafil, Sildenafil Company Name: Health Fixer Brand...