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February 12, 2021

FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy

For Immediate Release: February 12, 2021 Today, the U.S. Food and Drug Administration approved Cosela (trilaciclib) as the first therapy in its class to reduce the […]
February 12, 2021

Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy – 547409 – 02/04/2021

Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Mark H. Mandel, PharmD Recipient Title Owner and Pharmacist-in-Charge Snyder Mark Drugs Roselle, Inc. d.b.a. Mark […]
February 12, 2021

Village Pharmacy – 516174 – 02/01/2021

Delivery Method: Electronic Email Reference #: #17-NWJ-10 Product: Drugs Recipient: Recipient Name Ann Ervin Recipient Title Owner Village Pharmacy 1280 Yardville-Allentown RoadAllentown, NJ 08501-1830United States [email protected] […]
February 12, 2021

Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle

Summary Company Announcement Date: August 26, 2018 FDA Publish Date: March 19, 2020 Product Type: Drugs Over-the-Counter Drugs Reason for Announcement: Recall Reason Description Dosage cup […]
February 11, 2021

FDA’s Generic Drug Program in 2020 Helped Ensure Availability of High-Quality, Affordable Drugs Amid COVID-19

Image By: Sally Choe, Ph.D., Director, Office of Generic Drugs, Center for Drugs Evaluation and Research  Generic drugs play a vital role in facilitating access to […]
February 11, 2021

FDA approves add-on therapy for patients with genetic form of severely high cholesterol

FDA has approved Evkeeza (evinacumab-dgnb) injection as an add-on treatment for patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH), a genetic condition that causes […]
February 11, 2021

Recalls of Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan

Not all valsartan, losartan, and irbesartan-containing medications are affected and being recalled. Not all lots of valsartan, irbesartan, and losartan from a manufacturer involved in a […]
February 11, 2021

More Questions and Answers: Impurities Found in Certain Angiotensin II Receptor Blocker (ARB) products

We review information on impurity testing provided in drug applications and when inspecting manufacturing facilities. Manufacturers are required to test for impurities that may be introduced […]
February 11, 2021

Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan

A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) Valsartan 80mg Tablet 54569-6582-1  342B17019 09/2019 A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) Valsartan 80mg Tablet 54569-6582-1  342B17018 08/2019 […]
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