2010-7697. Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Amendment of Notice

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing an amendment to the notice of a joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This meeting was announced in the Federal Register of March 8, 2010 (75 FR 10490). The amendment is being made to reflect a change in the Agenda portion of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT:

Anuja Patel, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, 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), codes 3014512532 and 3014512535. Please call the Information Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION:

In the Federal Register of March 8, 2010, FDA announced that a joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee would be held on May 12, 2010. On page 10490, in the second column, the Agenda portion of the document is changed to read as follows:

Agenda: The committees will discuss new drug application (NDA) 22-478, naproxcinod 375 milligram capsule, sponsored by NicOx S.A. Naproxcinod is a non-steroidal anti-inflammatory drug (NSAID) product indicated for the treatment of the signs and symptoms of osteoarthritis.

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

Dated: April 1, 2010.

Jill Hartzler Warner,

Acting Associate Commissioner for Special Medical Programs.