Transcription of February 24, 2022 AstraZeneca Pharmaceuticals LP Attention ...
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February 24, 2022 AstraZeneca Pharmaceuticals LP Attention ...
May 17, 2022 AstraZeneca Pharmaceuticals LPAttention: Stacey Cromer Berman, PhDSenior Regulatory Affairs Director and Team Lead One MedImmune Way Gaithersburg, MD 20878 RE: Emergency Use Authorization 104 Dear Dr. Cromer Berman: This letter is in response to AstraZeneca Pharmaceuticals LP s ( AstraZeneca ) request that the Food and Drug Administration (FDA or Agency) issue an Emergency Use Authorization (EUA) for the emergency use of EVUSHELD (tixagevimab co-packaged with cilgavimab) for thepre-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kg), as described in the Scope of Authorization (Section II) of this letter, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 360bbb-3). On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes coronavirus disease 2019 (COVID-19).
AstraZeneca Pharmaceuticals LP . Attention: Stacey Cromer Berman, PhD . Senior Regulatory Affairs Director and Team Lead . One MedImmune Way . ... Cilgavimab injection (NDC 0310-1061-01) is a sterile, preservative-free, clear to opalescent and colorless to slightly yellow solution supplied in a single-dose vial for intramuscular use. The vial
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