Spero therapeutics receives complete response letter from u.s. food and drug administration for tebipenem hbr new drug application

Cambridge, mass., june 27, 2022 (globe newswire) -- spero therapeutics, inc. (nasdaq: spro) today announced that it has received a complete response letter (crl) from the u.s. food and drug administration (fda) for its new drug application (nda) seeking approval for tebipenem hbr oral tablets for treatment of adult patients with complicated urinary tract infection (cuti), including pyelonephritis. the fda had set a prescription drug user fee act (pdufa) target action date of june 27, 2022.
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