BRIDGEWATER, N.J. —Amneal Pharmaceuticals announced that it has received approval for its Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for acyclovir cream, 5%. Acyclovir cream, 5%, is the generic version of Zovirax for treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older. The product is available by prescription only and is associated with mild side effects such as nausea.

“Approval of our acyclovir cream, 5%, marks another milestone along our path toward providing more accessible, complex generic formulations to patients and to the U.S. healthcare system,” stated Chirag and Chintu Patel, co-chief executive officers. “Acyclovir cream, 5%, represents one of our complex drug products launched this year, which demonstrates the strength of our pipeline and the depth of our manufacturing capabilities. This approval is a precedent for Amneal as it is the first Topical Cream product to be approved based on innovative scientific strategy, which also demonstrates our technological advancements.”

According to IQVIATM U.S. annual sales for acyclovir cream, 5%, for the 12 months ended September 2020 were approximately $67 million.