FDA prolongs review of Lipocine's Tlando

Lipocine Inc. (NASDAQ:LPCN) said FDA extended by 3 months its review of Tlando testosterone undecanoate (LPCN 1021) to treat hypogonadism. The candidate’s new PDUFA date is May 8.

Lipocine said the agency lengthened the review period to allow time for analysis of data submitted by the company as an amendment to Tlando's NDA. Lipocine resubmitted the NDA after FDA issued a complete response letter in 2016 identifying problems with its proposed dose titration scheme for clinical practice, which Lipocine said “significantly differed” from the scheme used in a Phase III trial (see BioCentury, Aug. 18)...