Actinic keratoses cream gets thumbs-up

Bristol, Tenn. - The Food and Drug Administration (FDA) has approved Zyclara, a new cream made by Graceway Pharmaceuticals of Bristol, Tenn., for treatment of actinic keratoses, news source TriCities.com reports.

Zyclara shares the same active ingredient, imiquimod, as Graceway’s flagship product, Aldara cream. Zyclara can be applied on a more accelerated dosing schedule, and can treat larger areas of skin, such as an entire face or a balding scalp.

According to TriCities.com, the FDA approval comes at a crucial time for Graceway, as revenues from Aldara have declined steeply in recent weeks as a result of another drug-maker launching a similar, generic product. Graceway has filed a patent-infringment lawsuit against Nycomed in a New Jersey federal court, and is seeking an injunction against further distribution of the generic drug while that litigation is pending.