Document ID: FDA-2005-P-0314-0002
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-04-14T04:00Z

DEPARTMENT OF HEALTH & HUMAN SERVICES default		         		Public
Health Service

 ADVANCE \r360  ADVANCE \d3 	Food and Drug Administration

 ADVANCE \r360 	Rockville, MD  20857

April 14, 2005

Mr. Stephen D. Celestini

Salix Pharmaceuticals, Inc.

8540 Colonnade Center Drive

Suite 501

Raleigh, North Carolina  27615

Dear Mr. Celestini:

Your petition requesting the Food and Drug Administration to establish
guidance or regulations providing bioequivalence requirements for oral
locally-acting gastrointestinal(“GI”) drug products prior to
approval of any generic versions of such drugs,  was received by this
office on 04//13/2005. It was assigned docket number 2005P-0146/CP 1 
and it was filed on 04/14/2005.  Please refer to this docket number in
future correspondence on this subject with the Agency.

Please note that the acceptance of the petition for filing is a
procedural matter in that it in no way reflects an agency decision on
the substantive merits of the petition.

Sincerely,

Lyle D. Jaffe

Division of Dockets Management

Office of Management Programs

Office of Management