The U.S. Food and Drug Administration accepted Allergan plc and Paratek Pharmaceuticals Inc.'s new drug application for Seysara to treat moderate to severe acne vulgaris in patients aged 9 years or more.
The application includes two phase 3 studies evaluating Seysara, both of which had met their primary endpoints.
The company is expecting a potential U.S. approval for Seysara in the second half of 2018, said David Nicholson, Allergan's chief research and development officer.
Allergan has U.S. rights to the development and commercialization of Seysara, while Paratek retains all ex-U.S. rights.
