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Additionally, FDA does not consider convenience in administering a particular compounded drug product (e.g., a ready-to-use form) or the cost of the compounded drug product as compared with an FDA-approved drug product when assessing clinical need. The notice also states that the FDA carefully reviewed the nominations it received and it did not identify sufficient evidence to include semaglutide, tirzepatide, and liraglutide on the 503B Bulks List

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No test of humoral immunity in infant monkeys was conducted with evolocumab

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