04P-0140
C 1
Volume 1

Cover Letter

Table of Contents

Exhibit 1 - FDA March 1, 2004 letter from Gary J. Buehler, Director, Office of Generic Drugs, Center for Drug Evaluation, and Research to ANDA Applicants for Metaxalone Tablets

Exhibit 2 - Declaration of Dr. Paul Bass, Professor Emeritus of Pharmacology at the University of Wisconsin -Madison

Exhibit 3 - Morey, “Metaxalone, a New Skeletal Muscle Relaxant,” J. Am. Osteo. Ass’n, 62: 517-21 (1963)

Exhibit 4 - Fathie, “Musculoskeletal Disorders and Their Management with a New Relaxant,” Clinical Medicine, 72: 679-82 (1965)

Exhibit 5 - Carter, “A new muscle relaxant,” Diseases of the Nervous System 1962; 23(2): 98-100

Exhibit 6 - Albanese, Nurses’ Drug Reference at 427 (2d ed. 1982)

Exhibit 7 - 1990 Physicians’ Desk Reference at 831

Exhibit 8 - AHFS Drug Information 12:20 at 1325 (2003)

Exhibit 9 - Harden, “A review of three commonly prescribed skeletal muscle relaxants,” J. of Back and Musculoskeletal Rehab. 15: 63-66 (2000)

Exhibit 10 - Fathie, “A Second Look at a Skeletal Muscle Relaxant: A Double-Blind Study of Metaxalone,” Current Therapeutic Research, Vol. 6, No. 11: 677-83 (1964)

Exhibit 11 - Abrams, Clinical Drug Therapy 145-49 (1995)

Exhibit 12 - Drug Information for the Health Care Professional, USPDI Vol. I at 2449 (15th ed. 1995)

Exhibit 13 - Carroll, “The pharmacology of a new oxazolidinone with anticonvulsant, analgetic and muscle relaxant properties,” Arch. Int. Pharmacodyn., Vol. 80, No. 3-4: 280-98 (1961)

Exhibit 14 - Hamaguchi, “Effect of a high-fat meal on the bioavailability of phenytoin in a commercial powder with a large particle size,” Int’l. J. Clin. Pharmacol., Ther. and Tax., Vol. 31, No. 7: 326-330 (1993)

Exhibit 15 - Osol, Remington‘s Pharmaceutical Sciences at 867 (16th ed. 1980)

Exhibit 16 - Monograph No. 5838 of the Merck Index (11th ed., 1989)

Exhibit 17 - U.S. Patent No. 6,407,128

Exhibit 18 - October 2000 FDA Guidance for Industry "Bioavailability and bioequivalence studies for orally administered drug products - General considerations”

Exhibit 19 - Draft 1997 Guidance for Industry “Food-effect bioavailability and bioequivalence studies”

Exhibit 20 - US. Patent No. 6,683,102

Exhibit 21 - United States Patent Application No. 10/420,804

Exhibit 22 - May 31, 2002 letter from Lee S. Simon, Division Director, Division of Anti- Inflammatory, Analgesic and Opthalmic Drug Products, to Linda B. Fischer, Elan Pharmaceuticals, Inc.

Exhibit 23 - King Product Information, printed from http://www.kingphar.com/product_view.asp?KP_Product_ID=101

Exhibit 24 - Bass, Capsugel Symposia Series, Current Status on Targeted Drug Delivery to the Gastrointestinal Tract, “Gastric emptying: differences among liquid, fiber, polymer and solid dosage forms of medications,” Short Hills, NJ - April 22, 1993.

Exhibit 25 - Elan Clinical Study Report ELN151607-105, “A study to evaluate the pharmacokinetics of SkelaxinB (metaxalone) 2x400mg tablet administered to young and elderly volunteers under fed and fasted conditions”