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The proposed indication for ODEFSEY rilpivirine alafenamide is for use as a complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older with no antiretroviral treatment history or who are virologically suppressed to replace regimen. This collaborative review is written by the Division of Medical Policy Programs DMPP and the Office of Prescription Drug Promotion OPDP in response to a request by the Division of Antiviral Products DAVP on July 28 2015 for DMPP and...

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What is 208351orig1s000 - fda?

208351orig1s000 - fda is a form submitted to the FDA to request approval for a new drug.

Who is required to file 208351orig1s000 - fda?

Any pharmaceutical company seeking approval for a new drug is required to file form 208351orig1s000 - fda with the FDA.

How to fill out 208351orig1s000 - fda?

Form 208351orig1s000 - fda can be filled out electronically on the FDA's website or submitted in paper form via mail.

What is the purpose of 208351orig1s000 - fda?

The purpose of 208351orig1s000 - fda is to provide the FDA with necessary information about a new drug in order to obtain approval for its marketing and sale.

What information must be reported on 208351orig1s000 - fda?

Form 208351orig1s000 - fda requires detailed information about the new drug, its intended use, manufacturing process, potential risks, and clinical trial data.