NDA 211281, held by Braintree Labs. Lactitol.
As of Nov 14, 2026, NDA 211281 (Pizensy), held by Braintree Labs, was first approved by FDA on Feb 12, 2020, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 12, 2020 | Original applicationNew molecular entity · Standard review | Approved |
| Aug 17, 2021 | Supplement 1Labeling · Standard review | Approved | |
| Feb 12, 2020 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
