(c)  Molnupiravir has not been approved but has been authorized for emergency use by the FDA under an EUA to treat mild to moderate COVID-19 infection. Briefly explain this decision made by FDA based on the knowledge of clinical trials.  (d)  Both drugs are not allowed to be prescribed to person under 18 years old due to insufficient clinical data. Why is it necessary to separately conduct clinical trials for a younger age group?

Phlebotomy Essentials
6th Edition
ISBN:9781451194524
Author:Ruth McCall, Cathee M. Tankersley MT(ASCP)
Publisher:Ruth McCall, Cathee M. Tankersley MT(ASCP)
Chapter1: Phlebotomy: Past And Present And The Healthcare Setting
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  1. (c)  Molnupiravir has not been approved but has been authorized for emergency use by the FDA under an EUA to treat mild to moderate COVID-19 infection. Briefly explain this decision made by FDA based on the knowledge of clinical trials. 

  2. (d)  Both drugs are not allowed to be prescribed to person under 18 years old due to insufficient clinical data. Why is it necessary to separately conduct clinical trials for a

younger age group?

4. In March 2022, the Hong Kong government has purchased two types of drugs to treat COVID-
19, Paxlovid and Molnupiravir.
PAXLOVID"
a
150 mg + 100 mg
film-coated tablets
PF-07321332 and ritonavir
30 film-coated tablets
20 PF-07321332 tablets and 10 ritonavir tablets)
Figure 2: Paxlovid
NDC 0006-5055-06
molnupiravir
capsules
200 mg
For use under Emergency
Use Authorization (EUA)
Each capsule contains 200 mg molnupiravir.
Store at 20°C to 25 C (68F to 77 F), excursions
permitted to 15 Cto 30°C (59 F to 86 F).
Dispense in original container.
Scan QR code or go to www.molnupiravir.com
to access the
FDA-authorized
Fact Sheet for dosage
and administration.
Rx only
40 Capsules
Figure 3: Molnupiravir
3 0006-5055-06 0
Mand for: Merd Stap & Ouhme Co
Mand by:Paton antiak x. Ccn, CH 45237, USA
Transcribed Image Text:4. In March 2022, the Hong Kong government has purchased two types of drugs to treat COVID- 19, Paxlovid and Molnupiravir. PAXLOVID" a 150 mg + 100 mg film-coated tablets PF-07321332 and ritonavir 30 film-coated tablets 20 PF-07321332 tablets and 10 ritonavir tablets) Figure 2: Paxlovid NDC 0006-5055-06 molnupiravir capsules 200 mg For use under Emergency Use Authorization (EUA) Each capsule contains 200 mg molnupiravir. Store at 20°C to 25 C (68F to 77 F), excursions permitted to 15 Cto 30°C (59 F to 86 F). Dispense in original container. Scan QR code or go to www.molnupiravir.com to access the FDA-authorized Fact Sheet for dosage and administration. Rx only 40 Capsules Figure 3: Molnupiravir 3 0006-5055-06 0 Mand for: Merd Stap & Ouhme Co Mand by:Paton antiak x. Ccn, CH 45237, USA
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