Gilead Sciences (GILD) Gets FDA Approval for Viread as HIV-1 Treatment in Certain Patients
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Gilead Sciences, Inc. (Nasdaq: GILD) reports the U.S. Food and Drug Administration (FDA) has approved Viread (tenofovir disoproxil fumarate) in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2-12.
The FDA approved a supplemental New Drug Application (sNDA) for three lower-strength once-daily tablets of Viread in doses of 150 mg, 200 mg and 250 mg for children ages 6-12. The agency also approved a New Drug Application (NDA) for an oral powder formulation of Viread for children ages 2-5. The active ingredient in Viread, tenofovir disoproxil fumarate, is currently the most-prescribed molecule for adults receiving HIV therapy in the United States.
The FDA approved a supplemental New Drug Application (sNDA) for three lower-strength once-daily tablets of Viread in doses of 150 mg, 200 mg and 250 mg for children ages 6-12. The agency also approved a New Drug Application (NDA) for an oral powder formulation of Viread for children ages 2-5. The active ingredient in Viread, tenofovir disoproxil fumarate, is currently the most-prescribed molecule for adults receiving HIV therapy in the United States.
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