35 new drugs approved in 2011 in US

FDA: 35 innovative new drugs approved in fiscal year 2011 — Report shows quick approvals of safe and effective medicines occur in the United States before other countries – Over the past 12 months, the U.S. Food and Drug Administration approved 35 new medicines for patients, like two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin’s lymphoma in 30 years; and the first new drug for lupus in 50 years.

Kalbitor, ecallantide, approved for treating hereditary angioedema

FDA Approves Kalbitor for Treating Potentially Life-Threatening Attacks of Hereditary Angioedema – The U.S. Food and Drug Administration approved Kalbitor (ecallantide) to treat sudden and potentially life-threatening fluid buildup that can occur in people with a rare genetic condition known as hereditary angioedema (HAE).

Complete response letter for Cinryze for hereditary angioedema

ViroPharma Receives Complete Response Letter for Cinryze(TM) Supplemental Biologics License Application for Acute Treatment of Hereditary Angioedema – Company Also Granted Expansion of Prophylaxis Therapy Label to Include Patient Labeling for Self-Administration. – ViroPharma Incorporated (Nasdaq: VPHM) announced that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) related to its supplemental Biologics License Application (sBLA) for Cinryze(TM) (C1 esterase inhibitor [human]) as a treatment for acute attacks of hereditary angioedema (HAE).

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