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2006P-0522 Apply Bioequivalence Requirements Consistent with 21 CFR 320.24(b)(4) to any ANDA for a Generic Drug Product Using Lidoderm as its RLD

CP1

Citizen Petition

Tab A - October 5, 2006 Letter, Reference OGD #06-0100

Tab B - Galer, Bradley S. Chapter 887 Topcial Medications Copyright

Tab C - Rowbotham, Michael C. et al, Lidocaine patch: double-blind controlled study of a new treatment method for post-herpetic neuralgia; Pain, 65, (1996) pp 39-44 Copyright

Tab D - White, William T., et al, Lidocaine Patch 5% with Systemic Analgesics Such as Gabapentin: A Rational Polypharmacy Approach for the Treatment of Chronic Pain, Pain Medicine, vol. 4, Number 4, 2003, pp 321-330. Copyright

Tab E - Gammaitoni, Arnold R., et al, Pharmacokinetics and Safety of Continuously Applied Lidocaine Patche 5%, Am J Health-Syst Pharm to(22):2215-2220, 2002 Copyright

Tab F - Burch, F., et al., Lidocaine patch 5% improved pain, stiffness , and physical function in osteoarthritis pain patients, Osteoarthritis and Cartilate (2004) 12, 253-255 Copyright

Tab G - Galer, Bradley S, et al., Brief Report, Topical lidocaine patch 5% may target a novel underlying pain mechanism in osteoarthritis, Current Medical Research and Opinions, Vol. 20, No. 9, 2004, pp 1455-1456. Copyright

Tab H - Gimbel, Joseph, et al., Lidocaine Patch Treatment in Patients with Low Back Pain: Results of an Open-Label, Nonrandomized Pilot Study, American Journal of Therapeutics 12, 311-319 (2005) Copyright

Tab I - Campbell, Bryan J., et al., Systemic Absorpotion of Topical Lidocaine in Normal Volunteers, Patients with Post-Herpetic Neuralgia, and Patients with Acute Herpes Zoster, Journal of Pharmaceutical Sciences, Vol. 91, No. 5, May 2002, pp 1343-1350 Copyright

Tab J - Rowbotham, Michael C., et al., Both intravenous lidocaine and morphine reduce thepain of postherpetic neuralgia, Neurology, 41, July 1991, pp 1024-1028 Copyright

Tab K - Tremont-Lukats, Ivo W., et al., System Administration of Local Anesthetics to Relieve Neuropathic Pain: A Systematic Review and Meta-Analysis, Anesth Analg 2005;101:1738-49 Copyright

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