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Sernivo FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved February 5, 2016)
Brand name: Sernivo
Generic name: betamethasone dipropionate
Dosage form: Topical Spray
Company: Promius Pharma, LLC
Treatment for: Plaque Psoriasis

Sernivo Spray (betamethasone dipropionate) is a topical corticosteroid indicated for the treatment of mild to moderate plaque psoriasis.

The safety and efficacy of Sernivo Spray were evaluated in two double-blind clinical trials in which randomized subjects applied Sernivo Spray or vehicle spray to the affected areas twice daily for 28 days. At Day 29, Sernivo achieved treatment success of 42.7% and 34.5% compared to vehicle success rates of 11.7% and 13.6%, respectively.

Common side effects observed during clinical trials include pruritus, burning and/or stinging, pain, and atrophy at the application site.

Development timeline for Sernivo

Feb  7, 2016Approval Promius Pharma Receives FDA Approval for Sernivo (betamethasone dipropionate) Spray

Further information

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