fbpx
September 1, 2020

Dr. Reddy’s Laboratories Limited – 481160 – 08/27/2020

Reference #: 3002949085, 3005447965, and 3006549835 Product: Drugs Recipient: Recipient Name Mr. Satish Reddy Recipient Title Chairman Dr. Reddy’s Laboratories Limited 8-2-337, Road No. 3Banjara Hills, […]
September 1, 2020

Novel Drug Approvals for 2020

Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) […]
September 1, 2020

Mylan Laboratories Limited – Unit 7 – 607508 – 08/20/2020

Delivery Method: VIA UPS Reference #: 320-20-44 Product: Drugs Recipient: Recipient Name Ms. Heather Bresch Recipient Title Chief Executive Officer Mylan Laboratories Limited – Unit 7 […]
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: […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0