RFI_-Attachment_-2.pdf

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Attachment 2

The requirements listed in the table below shall be accommodated by the responder offering a complete procurement of Malaria Prophylactic Drug Tafenoquine brand name Arakoda. Please indicate Y (Yes) or N (No) if your offer meets each requirement in the requirement’s list below, and use the comments column to further justify how your product meets the requirement.

REQUIREMENTS/ SPECIFICATIONS

MEETS

REQUIREMENT?

(Y/N)

COMMENTS

1. Tafenoquine

a. FDA approved Tafenoquine succinate tablets for oral use, indicated for the prevention of malaria in adults for up to 6 months of continuous dosing.

b. Each tablet contains 100 mg of tafenoquine free base for oral use only.

c. The dosing regimen for tafenoquine consists of a loading dose of 2 x 100 mg tablets once daily for 3 days before travel to a malarious area, followed by weekly 2 x 100 mg maintenance doses while in the malarious area, followed by one dose of 2 x 100 mg in the week following exit from the malarious area.

d. Tafenoquine tablets can be taken with or without food.

e. Tafenoquine 100 mg tablets packed in blister packs of 8 tablets per blister card. A package of

Tafenoquine contains 16 tablets (two blister cards).

f. Tafenoquine tablets can be stored at 20°C to 25°C

(68°F to 77°F); with excursions permitted to 15-30°C

(59-86°F).

END