Just to clarify the approval process to those who may not know, an inspection of the manufacturing facility and all labeling requirements are finalized before approval. Which means once approved, theoretically the product can be distributed and used the same day. See the FDA's handy info sheet below
https://www.fda.gov/drugs/drug-information-consumers/fda-drug-approval-process-infographic-horizontal
Just to clarify the approval process to those who may not know,...
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