FDA tentatively approves Perrigo's generic HalfLytely, bisacodyl tablets bowel prep kit
ALLEGAN, Mich. The Food and Drug Administration has granted tentative approval to Perrigo’s generic version of a set of drugs used prior to colonoscopies, Perrigo said Wednesday.
PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablets is a generic version of Braintree Labs’ HalfLytely and bisacodyl tablets bowel prep kit. Perrigo acquired the rights to the regulatory approval application for the generic version from Novel Labs, and the FDA granted the tentative approval on Thursday.
Atentative approval means that a generic drug meets the FDA’s conditions for approval, but can’t be marketed until the patents covering the branded version have expired.