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September 1, 2020

Acella Pharmaceuticals, LLC – 604438 – 08/14/2020

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Harold A. Deas, Jr. Recipient Title Chief Executive Officer Acella Pharmaceuticals, LLC 1880 McFarland ParkwaySuite 110-BAlpharetta, […]
September 1, 2020

Drug Trials Snapshots: ENSPRYNG

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
August 31, 2020

Coronavirus (COVID-19) Update: Daily Roundup August 31, 2020

For Immediate Release: August 31, 2020 The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: The […]
August 31, 2020

Mylan Initiates Voluntary Nationwide Recall of Four Lots of Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP Due to Carton Label Mix-Up

Summary Company Announcement Date: August 28, 2020 FDA Publish Date: August 31, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Vials potentially packaged in […]
August 31, 2020

Open Book Extracts Issues Voluntary Nationwide Recall of All Lots of Always Be Clean Hand Sanitizer and Just Hand Sanitizer that are Labeled to Contain Methanol

Summary Company Announcement Date: August 29, 2020 FDA Publish Date: August 31, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Products labeled to contain […]
August 28, 2020

Coronavirus (COVID-19) Update: Daily Roundup August 28, 2020

For Immediate Release: August 28, 2020 The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic: […]
August 28, 2020

FDA Rationale for Recognition Decision: Daptomycin

As of August 24, 2020, the FDA-revised breakpoints (BPs), also referred to as susceptibility test interpretive criteria (STIC) for daptomycin for Enterococcus faecalis (including vancomycin-susceptible and […]
August 28, 2020

PDUFA VI: Assessment of Combination Product Review Practices in PDUFA VI

Combination products are therapeutic and diagnostic products that contain two or more types of medical products as constituent parts: a drug and device, a drug and […]
August 28, 2020

Harmonic Nature Issues Voluntary Nationwide Recall of Hand Sanitizer Due to the Presence of 1-Propanol

Summary Company Announcement Date: August 14, 2020 FDA Publish Date: August 28, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains 1 propanol […]
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