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September 29, 2022

FDA Approves New Treatment Option for Patients with ALS

For Immediate Release: September 29, 2022 The U.S. Food and Drug Administration today approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS), commonly […]
September 29, 2022

GDUFA II Enhanced Accountability & Reporting

The links below provide data on GDUFA metrics and are updated periodically: Activities Reports of the Generic Drug Program Additional Reports Content current as of: 01/18/2022 […]
September 29, 2022

The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities

On this page Podcast and newsletter Podcast Transcript Dr. Shannon Glueck – Branch Chief, Compounding Incidents Branch;Office of Compounding Quality and Compliance | CDER | FDA […]
September 29, 2022

The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities | Audio Transcript

Joan: Welcome to the CDER Small Business and Industry Assistance (SBIA) Chronicles Podcast Series. Today’s topic: The FDA Compounding Incidents Program: Adverse Events Associated with Compounded […]
September 29, 2022

FDA approves first treatment for prurigo nodularis

Action FDA has approved Dupixent (dupilumab) injection for the treatment of adults with prurigo nodularis (PN). This is the first FDA-approved treatment for PN. Dupixent is […]
September 29, 2022

Bespoke Apothecary LLC – 641573 – 09/28/2022

Product: Drugs Recipient: Recipient Name April Hart and Bill Krovetcz Bespoke Apothecary LLC 300 Sullivan Crest RoadElmira, NY 14901United States [email protected] WARNING LETTER RE: 641573 Date: […]
September 28, 2022

Proper Trade LLC/My Stellar Lifestyle Issues Voluntary Nationwide Recall of Wonder Pill Capsules Due to the Presence of Undeclared Tadalafil

Summary Company Announcement Date: September 27, 2022 FDA Publish Date: September 28, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains undeclared tadalafil […]
September 27, 2022

Eugia US LLC Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), Due to the Presence of Particulate Matter

Summary Company Announcement Date: September 27, 2022 FDA Publish Date: September 27, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of a dark […]
September 27, 2022

Zhejiang Tianyu Pharmaceutical Co., Ltd. – 631054 – 08/17/2022

Delivery Method: Return Receipt Requested Product: Drugs Recipient: Recipient Name Mr. Yongjun Tu Recipient Title Chief Executive Officer and Chairman of the Board Zhejiang Tianyu Pharmaceutical […]
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