Treats clinically important hypotension resulting primarily from vasodilation in the…. NDA 212909, held by Dr Reddys Labs SA. Phenylephrine Hydrochloride.
As of Nov 13, 2026, NDA 212909 (Biorphen), held by Dr Reddys Labs SA, was first approved by FDA on Oct 21, 2019, with 2 approved supplements and 0 published complete response letters.
BIORPHEN is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 11, 2021 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Oct 21, 2019 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Biorphen0.5MG/5ML (0.1MG/ML) · solution;intravenous | Phenylephrine Hydrochloride | RxReference drug |
| Biorphen10MG/ML (10MG/ML) · solution;intravenous | Phenylephrine Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 12, 2024 | Supplement 2Manufacturing | Approved | |
| Mar 11, 2021 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Oct 21, 2019 | Original applicationNew formulation or manufacturer · 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
