Merck & Co., Inc.
Merck Announces FDA Acceptance of Supplemental New Drug Application for ISENTRESS® raltegravir in Adult Patients Previously Untreated for HIV-1
Published in Medical Letter on the CDC and FDA, January 4th, 2009
Merck & Co., Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) filing for ISENTRESS® (raltegravir) Tablets for standard review. The Company is seeking United States marketing approval of ISENTRESS in combination with other HIV medicines for treatment in adult patients who are previously untreated (naive) for HIV. Merck expects FDA action in July 2009. “Merck has a long-standing commitment to the research and development of novel treatments for patients infected with HIV,” said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "Based on the results of our clinical program in treatment-naive patients, we are...
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