FDA (Food and Drug Administration) approved less than 12 months ago. The FAA requires at least one-year of post-marketing experience with a new drug before considering if for aeromedical certification purposes. New antibiotics, lipid-lowering drugs, and antihypertensive medications may be considered earlier than one year. Please contact the RFS or AMCD for guidance on specific applicants.
Senior AME here. you are correct about the 12 month rule on meds, but they made an exception for the covid jabs.