⚖️ Last week’s warning letter from the FDA to Empower pharmacy may have substantially lowered the stakes for Lilly in their lawsuit against the FDA on retatrutide’s designation.
If compounding is reigned in by the FDA to actually just cover scripts for patients truly requiring a compounded product, not merely as a stand-in for a low cost generic, then Lilly has a lot less to lose if Reta is still deemed a drug.
They’d obviously love a few more years of exclusivity and the extra hoops for getting a bio similar approved, but, make no mistake, compounding is the big reason Lilly wants the biologic designation.
😲Huge. FDA finally saying that the quantities of scripts involved in alternate formulations of semaglutide and tirzepatide by 503As appears to be “pretextual”.