The filing represents the fifth ANDA Acella has waiting approval from the FDA, the company said.
Acella develops a range of specialty pharmaceutical and other products in the areas of dermatology, women’s health, pediatrics and other applications.
Acella R&D head and vice president Allen Fields said the filing speaks to the quality of work performed by their team.
Acella CEO Mark Pugh said the filing is another example of their investment in new products and expansion of their diversified product portfolio.