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Alza’s fentanyl TTS patch

Executive Summary

Received intensive final stage FDA review at "NDA Day" held July 30. Reportedly, the narcotic analgesic patch is expected to be approved within weeks. The NDA, filed in December 1987, has been under the purview of FDA's Pilot Drug Evaluation staff ("The Pink Sheet" May 21, T&G-4). TTS-fentanyl is designed for patients with severe, long-term pain often associated with cancer or for patients with acute postoperative pain. Janssen will market the novel dosage form in the U.S. and other countries. Alza has the right to co-promote TTS-fentanyl to U.S. oncologists.
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PS017844

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