GASTROINTESTINAL DRUGS ADVISORY COMMITTEE
DATE AND TIME: January 23, 8:00 a.m.
LOCATION: Hilton Washington DC/Silver Spring, Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD
CONTACT: Mimi Phan, Center for Drug Evaluation and Research, 301-827- 7001. The committee will discuss the safety and efficacy of new drug application (NDA) 21-775, ENTEREG (alvimopan), Adolor Corp., for the proposed indication of acceleration of time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. More Information
DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE
DATE AND TIME: February 1, 8:00 a.m.
LOCATION: Hilton Washington DC/Silver Spring, Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD
CONTACT: Teresa Watkins, 301-827-7001. The committee will discuss the efficacy and safety of new drug application (NDA) 22-054, INJECTAFER (ferric carboxymaltose injection), Luitpold Pharmaceuticals Incorporated, used for the treatment of iron deficiency anemia in patients. More Information
CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE
DATE AND TIME: February 5, 12:00 p.m.
LOCATION: National Institutes of Health, Building 29B, Conference Room C, 9000 Rockville Pike, Bethesda, MD. This meeting will be held by teleconference. The public is welcome to attend the meeting at the specified location. A speaker phone will be provided at the specified location for public participation in the meeting, on site.
CONTACT: Gail Dapolito or Danielle Cubbage, 301-827-0314. The committee will meet in open session to hear updates of research programs in the Division of Therapeutic Proteins and the Division of Monoclonal Antibodies, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA. More Information
PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE
DATE AND TIME: February 6, 8:00 a.m.
LOCATION: Crowne Plaza Silver Spring, Kennedy Ballroom, 8777 Georgia Ave., Silver Spring, MD
CONTACT: Diem-Kieu Ngo, Center for Drug Evaluation and Research, 301-827-7001. The committee will discuss new drug application (NDA) 22- 173, ZYPREXA ADHERA (olanzapine pamoate depot) long acting intramuscular injection (210 milligrams (mg), 300 mg, and 405 mg per/ vial), Eli Lilly and Co., for the treatment of schizophrenia. A particular safety concern for discussion is the occurrence of severe somnolence in some patients who are administered this depot formulation of olanzapine. More Information
PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE
DATE AND TIME: February 20, 8:00 a.m.
LOCATION: National Labor College, Lane Kirkland Center, Solidarity Hall, 10000 New Hampshire Avenue, Silver Spring, MD
CONTACT: Teresa A. Watkins, Center for Drug Evaluation and Research, 301-827-7001. The committee will discuss the new drug application (NDA) 22-150, icatibant solution for injection (proposed tradename FIRAZYR), by Jerini, for the proposed indication of treatment of attacks of hereditary angioedema. More Information
tag: FDA, FDA Meetings, ENTEREG, gastrointestinal Drugs, DRUG SAFETY, Monoclonal Antibodies, Biotechnology Products, PSYCHOPHARMACOLOGIC DRUGS, ZYPREXA ADHERA, Eli Lilly, schizophrenia, PULMONARY-ALLERGY DRUGS, FIRAZYR, Jerini,
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