Page 8 – Eli Lilly and Company positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. V. All descriptive printed matter, as well as advertising and promotional material, relating to the use of the bamlanivimab clearly and conspicuously shall state that: x the bamlanivimab has not been approved, but has been authorized for emergency use by FDA, to treat mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. x the bamlanivimab is authorized for the treatment of mild to moderate COVID- 19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. IV. Durationof Authorization This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act. Sincerely, Digitally signed by Denise M. Denise M. Hinton -S3 Hinton -S3 Date: 2020.11.10 12:38:07 -05'00' ____________________________ RADM Denise M. Hinton Chief Scientist Food and Drug Administration Reference ID: 4699500