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Supplemental New Drug Application Submitted to FDA for NUCYNTA® ER (Tapentadol) Extended-Release Tablets for Diabetic Peripheral Neuropathic Pain
Date:10/31/2011

Pharmaceuticals, Inc., an affiliated company that holds the NDA for NUCYNTA® ER. Janssen Pharmaceuticals, Inc., markets NUCYNTA® ER in the United States.

This filing represents the ongoing commitment of J&JPRD and Janssen to bring new and innovative products to patients and physicians for the treatment and management of pain.

About Tapentadol, NUCYNTA® ER and NUCYNTA®

Tapentadol is a centrally acting synthetic analgesic. The tapentadol molecule is classified as Schedule II of the Controlled Substances Act.

NUCYNTA® ER (tapentadol) extended-release tablets represents the ongoing commitment of Janssen Pharmaceuticals, Inc. and J&JPRD to bring new and innovative products to patients and physicians for the treatment and management of pain.

NUCYNTA® ER is an oral analgesic indicated for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. It is taken twice daily and is available in 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths.

NUCYNTA® (tapentadol) immediate-release tablets was approved by the FDA on November 20, 2008, for the relief of moderate to severe acute pain in patients 18 years of age or older. It is available in 50 mg, 75 mg, and 100 mg strengths.

Both NUCYNTA® and NUCYNTA® ER are available by prescription only.

Outside the United States, tapentadol is marketed by Janssen Inc. in Canada; Grunenthal GmbH discovered tapentadol and markets immediate- and extended-release formulations of tapentadol (PALEXIA®) in various countries in Europe.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Janssen Pharmaceutic
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SOURCE Janssen Pharmaceuticals Research & Development
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