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Amneal obtains FDA nod for generic Zovirax


Patients with recurrent cold sores will soon have a new generic treatment available.

The Food and Drug Administration has cleared Amneal’s acyclovir cream in a dosage strength of 5%.

The product is the generic of GlaxoSmithKline’s Zovirax.

It is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older.

“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,” Chirag and Chintu Patel, Co-CEOs said. “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.”

Acyclovir cream had a market value of roughly $67 million for the 12 months ended September 2020, according to IQVIA.

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