1995S-0316
RPT 253
Volume 185

Cover Page

Letter from CFSAN to AIBMR Life Sciences, Inc.

New Dietary Ingredient Notification for N-Acetyl-L-Hydroxyproline

Reference 1 - Product description of AHYP, issued by Chephasaar Chem.-Pharm. Fabrik GmbH., St. Ingbert, Austria.

Reference 2 - Acute oral toxicity study of N-acetyl-L-hydroxyproline with 14-day post-treatment observation period in the rat (limit test). Final Report, #PDCL 0402 (2004).
Tables

Reference 3 - Redacted

Reference 4 - Schubotz R et al. Treatment of osteoarthritis with N-acetyl-hydroxyproline. Therapiewoche 27, 4248 (1977).

Reference 5 - Finkbeiner G et al. Conservative gonarthrosis therapy with Oxaceprol. Therapiewoche, 36 (2), 116 (1986).

Reference 6 - Michael J et al. Therapy of coxarthrosis and gonarthrosis with Oxaceprol. Therapiewoche, 36 (29), 3076 (1986).

Reference 7 - Diehl K et al. Therapy of chondropathia patellae with Oxaceprol. Therapiewoche, 35 (28), 3388 (1985).

Reference 8 - Diehl K et al. Therapy of gonarthrosis with Oxaceprol. Therapiewoche, 35 (1), 51 (1985).

Reference 9 - Laborie G et al. The acetyl-hydroxyproline, metabolic harmonization of connective tissue (100 cases in rheumatologic practice). Bordeaux Medical. 3, 3059 (1970).

Reference 10 - Lachmann G et al. Pharmacokinetics and metabolism of Carbon 14-Oxaceprol in beagle dogs after intramuscular and oral administration. Arzneimittel-Forschung, 40, 200-6 (1990).

Reference 11 - Herrmann G et al. Oxaceprol is a well-tolerated therapy for osteoarthritis with efficacy equivalent to Diclofenac. Clinical Rheumatology, 19, 99-104 (2000).

Reference 12 - Dreher DM. N-Acetyl-L-Hydroxyproline: Acute Oral Toxicity In the Rat-Acute Toxic Class Method. SPL Project Number: 732/093 (2001).

Reference 13 - Bowles AJ. N-Acetyl-L-Hydroxyproline: Reverse Mutation Assay “Ames Test” Using Salmonella Typhimurium and Escherichia Coli. SPL Project Number: 732/091 (2001).

Reference 14 - Wright NP et al. N-Acetyl-L-Hydroxyproline: Chromosome Aberration Test in CHL cells In Vitro. SPL Project Number: 732/092 (2001).

Reference 15 - Franz M. The Treatment of Degenerative Joint Diseases with Oxaceprol. Rheuma, 12 (4), 139- 143 (1992)