Strativa gets FDA approval for opharyngeal candidiasis drug

WOODCLIFF LAKE, N.J. The Food and Drug Administration has approved a new drug from Strativa Pharmaceuticals for treating thrush, the drug maker said Friday.

Strativa announced the FDA’s approval of Oravig (miconazole), a tablet intended for patients 16 and older with thrush, also known as oropharyngeal candidiasis. The company said Oravig was the first oral, local prescription formulation of miconazole approved for thrush in the United States. The drug is a buccal tablet, meaning it adheres to the gum to deliver the miconazole directly at the local site of infection.

“The FDA approval of Oravig underscores Strativa’s commitment to improving patients’ overall treatment experience by bringing to market new products that fulfill patient needs,” Strativa president John MacPhee said. “Oravig offers patients suffering from thrush a proven, effective treatment in a discreet and convenient once-daily formulation.”