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Jul31
USFDA Approved sNDA for Novartis Pharma Corp.’s Antiviral Agent Famvir®
Novartis Pharmaceuticals Corporation's sNDA for Famvir® (famciclovir) tablets has been approved by the USFDA as a single-day treatment for immunocompetent patients with recurrent genital herpes (RGH).

"Famvir is the first and only antiviral approved to treat recurrent genital herpes in a single day," said Gregory Geba, MD MPH, Vice President and Therapeutic Area Head of Respiratory, Dermatology and Infectious Diseases, Novartis Pharmaceuticals Corporation.

"The new data demonstrates that Famvir can minimize a recurrent genital herpes outbreak, and stop symptoms such as pain and burning, in a median of less than a day. More importantly, Famvir can also stop an outbreak from occurring altogether in many patients."

Genital herpes, one of the most common sexually transmitted diseases in the United States, infects 1 in 5 Americans (approximately), 90% of which doesn’t even know that they are infected. This condition has NO cure. Oral antiviral drugs like Famvir® are only indicated to suppress RGH.

On the other hand, cold sores (medically, herpes labialis) are an infection of the mouth area with the herpes simplex virus. Like RGH, there is no cure for cold sores and oral antiviral medications can just shorten the course of an outbreak and improve the time to resolution of symptoms (pain and tenderness).

Famvir®, also been USFDA approved as a single-dose treatment for recurrent herpes labialis (cold sores) in immunocompetent patients, has already been previously approved for the treatment of recurrent mucocutaneous herpes simplex infections in HIV-infected patients and the treatment of acute herpes zoster (shingles).

Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS).

Source: PR Newswire

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