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September 2, 2020

1 Party At A Time – 609781 – 09/01/2020

Product: Drugs Recipient: Recipient Name Dmitry Kats 1 Party At A Time 700 Bolinwood Dr., Apt. 26 CChapel Hill, NC 27514United States [email protected] Date:     September 1, […]
September 1, 2020

The Protein Shoppe, LLC Issues Voluntary Nationwide Recall of the “Red- E” Male Enhancement Tablet Due to the Presence of Undeclared Sildenafil

Summary Company Announcement Date: September 01, 2020 FDA Publish Date: September 01, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains undeclared sildenafil […]
September 1, 2020

FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia

On September 1, 2020, the Food and Drug Administration approved azacitidine tablets (ONUREG®, Celgene Corporation) for continued treatment of patients with acute myeloid leukemia who achieved […]
September 1, 2020

CDER-CFSAN Agreement

Inter-center Agreement between the Center for Drug Evaluation and Research and the Center for Food Safety and Applied Nutrition to Assist FDA in Implementing the Drug […]
September 1, 2020

FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs

For Immediate Release: September 01, 2020 Statement From: Statement Author Leadership Role Commissioner of Food and Drugs – Food and Drug Administration Stephen M. Hahn M.D. […]
September 1, 2020

FDA approves weekly therapy for adult growth hormone deficiency

[9/1/2020] The U.S. Food and Drug Administration approved Sogroya (somapacitan) on August 28 for adults with growth hormone deficiency. Sogroya is the first human growth hormone […]
September 1, 2020

Control of Nitrosamine Impurities in Human Drugs

Docket Number: FDA-2020-D-1530 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance recommends steps manufacturers of APIs and drug products should take […]
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) […]
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