Pharmaceutical group Galen Holdings said the US Food and Drug Administration has approved its Ovcon 35 oral contraceptive in chewable tablet form.
Galen filed a New Drug Application for the product in March last year and received an ''Approvable Letter'' from the FDA in January this year.
"This final approval signals that the outstanding issues addressed in that letter have now been resolved to the satisfaction of the agency," Galen said.
The current form of Ovcon 35 is marketed in the US by Galen unit Warner Chilcott.
"The new product gives the option to chew or swallow and has a pleasant flavour," Galen said. "It is designed to enhance both convenience and compliance for patients taking oral contraceptives."
