Graceway receives regulatory approval for Zyclara

BRISTOL, Tenn. — The Food and Drug Administration has approved a drug made by Graceway Pharmaceuticals for actinic keratoses, Graceway said.

The agency approved Zyclara (imiquimod) cream in the 2.5% strength for AK, a precancerous lesion that affects about 10 million Americans and can develop into skin cancer later on.

“The addition of a 2.5% formulation of Zyclara cream will provide healthcare practitioners greater flexibility when prescribing imiquimod therapy for patients with actinic keratoses,” New York University Medical Center dermatology professor and former American Academy of Dermatology president Darrell Rigel said. “The lower concentration offers greater tolerability while maintaining the efficacy that has been long associated with imiquimod.”