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March 11, 2021

Remarks by FDA Chief Scientist Denise Hinton to the Professional Services Council FedHealth Conference – 03/11/2021

Speech by Denise Hinton Leadership Role (Remarks as prepared for delivery) I’m delighted to be with you for this important meeting. Your agenda encompasses many of […]
March 11, 2021

Metuchen Pharmaceuticals, LLC – 590713 – 09/18/2020

Reference #: NDA 202276 Product: Drugs Recipient: Recipient Name Fady Boctor Metuchen Pharmaceuticals, LLC 200 US Hwy 9 Suite 500Manalapan, NJ 07726United States Issuing Office: Office […]
March 11, 2021

The Food and Drug Administration approved revisions to the TRIUMEQ (abacavir/dolutegravir/lamivudine) and DOVATO (dolutegravir/lamivudine) labels

The Food and Drug Administration approved revisions to the TRIUMEQ (abacavir/dolutegravir/lamivudine) and DOVATO (dolutegravir/lamivudine) labels to include dosing in patients with creatinine clearance between 30 and […]
March 11, 2021

Know Your Treatment Options for COVID-19

[embedded content] Patients today have more treatment options in the battle against coronavirus disease. The U.S. Food and Drug Administration has approved one drug treatment for […]
March 10, 2021

FDA approves tivozanib for relapsed or refractory advanced renal cell carcinoma

On March 10, 2021, the Food and Drug Administration approved tivozanib (Fotivda, AVEO Pharmaceuticals, Inc.), a kinase inhibitor, for adult patients with relapsed or refractory advanced […]
March 10, 2021

Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Spironolactone 25 mg and 50 mg Tablets Due to Mislabeling with the Incorrect Strength (Revision to Press Release with Same Title Dated 3/9/2021. Revision Includes Number of Bottles Impacted by Recall)

Summary Company Announcement Date: March 09, 2021 FDA Publish Date: March 09, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Incorrect strength displayed on […]
March 10, 2021

PDUFA V Meetings

This page includes information about the meetings that were held for PDUFA V. Find the archived information below on PDFUA V Meetings. PDUFA Public Meeting October […]
March 10, 2021

Industry Letters

Find industry letters from the Center for Drug Evaluation and Research (CDER) on Search for FDA Guidance Documents. Filter by FDA Organization and select Center for Drug […]
March 10, 2021

Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Spironolactone 25 mg and 50 mg Tablets Due to Mislabeling with the Incorrect Strength

Summary Company Announcement Date: March 09, 2021 FDA Publish Date: March 09, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Incorrect strength displayed on […]
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