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February 24, 2021

Untitled Letters 2019

These letters are supplied by the CDER Freedom of Information Office and only covers Office of Prescription Drug Promotion’s untitled letters.  The agency may have redacted […]
February 24, 2021

Untitled Letters 2020

These letters are supplied by the CDER Freedom of Information Office and only covers Office of Prescription Drug Promotion’s untitled letters.  The agency may have redacted […]
February 24, 2021

Untitled Letters 2021

These letters are supplied by the CDER Freedom of Information Office and only covers Office of Prescription Drug Promotion’s untitled letters.  The agency may have redacted […]
February 23, 2021

Coronavirus (COVID-19) Update: February 23, 2021

For Immediate Release: February 23, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
February 23, 2021

2020 First Generic Drug Approvals

  ANDA Number Generic Name ANDA Applicant Brand Name ANDA Approval Date ANDA Indication+ 72 208086 Glucagon for Injection USP, 1 mg/vial packaged in an emergency […]
February 23, 2021

Absara Cosmetics S.A.P.I DE C.V. – 612455 – 02/18/2021

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Daniel Chamlati Recipient Title Chief Executive Officer Absara Cosmetics S.A.P.I DE C.V. Autopista Mexico – Toluca […]
February 23, 2021

CooperSurgical, Inc. – 613339 – 02/12/2021

Product: Drugs Recipient: Recipient Name Holly Sheffield Recipient Title President CooperSurgical, Inc. 75 Corporate DriveTrumbull, CT 06611United States Issuing Office: The Office of Prescription Drug Promotion […]
February 22, 2021

FDA approves cemiplimab-rwlc for non-small cell lung cancer with high PD-L1 expression

On February 22, 2021, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with advanced non-small cell lung […]
February 22, 2021

Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

For Immediate Release: February 22, 2021 Today, the U.S. Food and Drug Administration issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, […]
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