The Psychopharmacologic Drugs Advisory Committee will hold a public meeting to 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.
The meeting will be Feb. 6, 2008, from 8 a.m. to 5 p.m.
Location:
Crowne Plaza Silver Spring, Kennedy Ballroom
8777 Georgia Ave.
Silver Spring, Md.
The hotel phone number is 301-587-4791.
Contact Person:
Diem-Kieu Ngo
Center for Drug Evaluation and Research (HFD-21)
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
301-827-7001
FAX: 301-827-6776
e-mail: diemkieu.ngo@fda.hhs.gov
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512544.
Background material is available.
Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m.