2023-05-01 09:33:13 ET
- The U.S. Food and Drug Administration (FDA) accepted Bausch Health Companies' ( NYSE: BHC ) application seeking approval of IDP-126 (clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%) gel to treat acne vulgaris.
- The FDA is expected to make a decision on the new drug application (NDA) by Oct. 20.
- The company said that if approved, IDP-126 has the potential to be the first of its kind fixed dose triple combination therapy for acne vulgaris.
- The NDA was backed by data from two phase 3 trials.
For further details see:
Bausch Health's IDP-126 gel for acne gets FDA review