E6-13502. Psychopharmacologic Drugs Advisory Committee; Amendment of Notice

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of the meeting of the Psychopharmacologic Drugs Advisory Committee. The meeting was announced in the Federal Register of July 20, 2006 (71 FR 41220). The amendment is being made to reflect a change in the Date and Time and Agenda portion of the notice. The Agenda scheduled for September 7, 2006, has been cancelled. The Agenda portion scheduled for September 8, 2006, has been moved to September 7, 2006. There are no other changes.

FOR FURTHER INFORMATION CONTACT:

Cicely Reese, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: [phone], e-mail: [e-mail], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512544.

SUPPLEMENTARY INFORMATION:

In the Federal Register of July 20, 2006, FDA announced that a meeting of the Psychopharmacologic Drugs Advisory Committee would be held on September 7, 2006, to discuss new drug application (NDA) 21-999, paliperidone extended-release (ER) tablets, Janssen, L.P./Johnson & Johnson Pharmaceutical Research and Development, L.L.C., proposed indication for treatment of schizophrenia and on September 8, 2006, to discuss NDA 21-992, desvenlafaxine succinate (DVS 233), ER tablets, Wyeth Pharmaceuticals, proposed indication for treatment of major depressive disorder. On page 41220, in the first column, the Date and Time portion of the meeting is amended to read as follows:

Date and Time: The meeting will be held on September 7, 2006, from 8 a.m. to 5 p.m.

On page 41220, second column, the Agenda portion of the meeting is amended to read as follows:

Agenda: On September 7, 2006, the committee will discuss new drug application (NDA) 21-992, desvenlafaxine succinate (DVS 233), extended-release tablets, Wyeth Pharmaceuticals, proposed indication for treatment of major depressive disorder (MDD).

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

Dated: August 8, 2006.

Randall W. Lutter,

Associate Commissioner for Policy and Planning.