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February 3, 2023

Generic Drugs Program Activities Report – FY 2022 Monthly Performance

GDUFA YEAR/Actions This Month 21-Oct 21-Nov 21-Dec 22-Jan 22-Feb 22-Mar 22-Apr 22-May 22-Jun 22-Jul 22-Aug 22-Sep FY-2022 Refuse to Receive (RTR) – Originals 3 3 3 […]
February 3, 2023

Alchymars ICM SM Private Limited – 542879 – 01/31/2023

Reference #: FEI 3005216842 Product: Drugs Recipient: Recipient Name Mr. K. Nagaradjan Recipient Title General Manager and Director Alchymars ICM SM Private Limited A-14 & 20 […]
February 3, 2023

Malladi Drugs & Pharmaceuticals Ltd. – 541915 – 01/31/2023

Reference #: 3005115135 Product: Drugs Recipient: Recipient Name Mr. V.N. Gopalkrishnan Recipient Title Co-Founder & Chairman Malladi Drugs & Pharmaceuticals Ltd. SKCL Tech Square, 7th Floor, […]
February 2, 2023

Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination

Summary Company Announcement Date: February 02, 2023 FDA Publish Date: February 02, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential microbial contamination Company […]
February 2, 2023

FY 2022 GDUFA Science and Research Report

The FY 2022 GDUFA science and research report describes active research projects and outcomes organized in 13 scientific areas. In each area, we summarize the relevant […]
February 2, 2023

Public Notification: MANNERS Energy Boost contains hidden drug ingredient

[2-2-2023] The Food and Drug Administration is advising consumers not to purchase or use MANNERS Energy Boost, a product promoted and sold to boost energy on […]
February 2, 2023

From Our Perspective | CDER’s Continued Efforts to Widen Naloxone Access

By: Marta Sokolowska, Ph.D., CDER Deputy Center Director for Substance Use and Behavioral Health Marta Sokolowska, Ph.D. The overdose crisis is one of the most devastating […]
February 1, 2023

FDA Approves First Oral Treatment for Anemia Caused by Chronic Kidney Disease for Adults on Dialysis

For Immediate Release: February 01, 2023 Today, the U.S. Food and Drug Administration approved Jesduvroq tablets (daprodustat) as the first oral treatment for anemia (decreased number […]
February 1, 2023

IBSA Pharma Inc. Issues Voluntary Nationwide Recall of Select Lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution Due to Subpotency

Summary Company Announcement Date: January 31, 2023 FDA Publish Date: February 01, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Subpotency Company Name: IBSA […]
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