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Biotech Stocks Facing FDA Decision In February

Bausch Health Companies
Bausch Health Companies

The FDA decision on Bausch Health Companies Inc.’s (BHC) Duobrii, proposed for the topical treatment of plaque psoriasis, is expected on February 15, 2019.

Duobrii, formerly known as IDP-118, is a fixed combination of Halobetasol, a corticosteroid, and Tazarotene, a retinoid, formulated as a once-daily lotion.

This is Duobrii’s second go-around with the U.S. regulatory agency. The FDA had refused to approve the product last June raising questions regarding pharmacokinetic data.

If approved, Duobrii will be the first and only topical lotion that contains the unique combination of Halobetasol and Tazarotene in one formulation for the treatment of plaque psoriasis in adult patients, allowing for a potentially expanded duration of use; for the patient with more moderate-to-severe disease, chronic or long-lasting episodes and thicker, stubborn plaques.

Bausch is planning to launch Duobrii this quarter (Q1, 2019).

BHC closed Tuesday’s (Jan.29, 2019) trading at $24.16, down 0.08%.