At least five PDUFA dates on FDA’s May docket

Only five PDUFA dates have been disclosed in May, with the month’s lone new product a 505(b)(2) NDA for a new formulation of an approved molecule.

Cingulate Inc. (NASDAQ:CING) is seeking approval of CTx-1301 for once-daily treatment of ADHD. The tablet is designed with three dexmethylphenidate-containing layers separated by barriers that erode sequentially, releasing doses at baseline and then three and seven hours later. Generic dexmethylphenidate is already available in immediate- and extended-release formulations...