Lupin Limited gets FDA tentative approval for rosacea drug generic

India-based Lupin Limited said that it has obtained tentative approval for its abbreviated new drug application (ANDA) of Doxycycline Capsules, 40 mg from the US Food and Drug Administration (FDA).

Doxycycline Capsules, 40 mg is the generic version of Oracea Capsules, 40 mg, of Galderma Laboratories.

Oracea, which is a tetracycline class medicine, is used for the treatment of rosacea, which is a common condition of the skin that results in blushing or flushing and making blood vessels visible on the face.

According to IQVIA MAT September 2022, Oracea had estimated sales of $215 million per year in the US.