NDA 214200, held by Pharmacosmos. Trilaciclib Dihydrochloride.
As of Nov 13, 2026, NDA 214200 (Cosela), held by Pharmacosmos, was first approved by FDA on Feb 12, 2021, with 3 approved supplements and 0 published complete response letters.
COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 12, 2021 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| CoselaEQ 300MG BASE/VIAL · powder;intravenous | Trilaciclib Dihydrochloride | RxReference drug |
| Aug 25, 2025 | Supplement 7Labeling · Standard review | Approved | |
| Aug 3, 2023 | Supplement 6Labeling · Standard review | Approved | |
| Apr 5, 2023 | Supplement 4Labeling · Standard review | Approved | |
| Feb 12, 2021 | Original applicationNew molecular entity · Priority 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
