- Tazarotene lotion 0.045% (Ortho Dermatologics) has been approved by the FDA for topical treatment of acne vulgaris in patients aged 9 years and older.
Why this matters
- This is the first approved tazarotene acne treatment available in lotion form.
- Tazarotene in different formulations is approved for various indications in Europe.
- Approval was based on data from 2 phase 3 randomized controlled trials.
- In both trials, tazarotene lotion 0.045% was associated with the attainment of primary efficacy endpoints (P<.001>
- Tazarotene lotion 0.045% was generally well-tolerated in the clinical study population.