This article is more than 5 years old. Information may no longer be current.

Perrigo: FDA approves generic version of Vanos fluocinonide cream

The FDA has awarded final approval for an abbreviated new drug application for fluocinonide cream 0.1%, manufacturer Perrigo Company announced.

Fluocinonide cream 0.1% is the generic equivalent to Vanos Cream 0.1% (Medicis Pharmaceutical), a corticosteroid that is indicated for treating inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients aged 12 years and older, according to a press release. A generic drug exclusivity of 180 days was awarded to Perrigo because it was the first company to submit an abbreviated new drug application containing a paragraph IV certification, the release stated.

Product shipment has begun after resolution of litigation with the brand, Perrigo announced.

“This is another example of our [generic prescription] team’s commitment to launching difficult-to-manufacture topicals, lotions and foams,” Joseph C. Papa, Perrigo president and chief executive officer, said in the release. “We are excited to market this product.”