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Pfizer, Allergan And Schering NMEs Receive Second “Approvable” Letters

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pfizer’s anidulafungin received a second “approvable” letter Nov. 25 for treatment of esophageal candidiasis, FDA said.

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Schwarz Neupro "approvable"

Schwarz' early-stage Parkinson's treatment Neupro (rotigotine transdermal system) is "approvable" pending submission of "additional analyses and summaries from the existing database," the firm announces March 1. "We anticipate responding to the action letter within six months," the company says. FDA's decision on the new molecular entity comes after the agency extended its user fee date by 90 days (1Pharmaceutical Approvals Monthly December 2005, p. 5). Schwarz plans to submit an sNDA for advanced Parkinson's by the end of 2006; Phase III results in restless legs syndrome are expected in the first quarter of 2007...

Inspire ends denufosol retinal program

Inspire discontinues its Phase II pilot trials of the P2Y2 agonist denufosol (INS37217) for macular edema "and has no plans to conduct any further studies of denufosol for the treatment of retinal disease," the firm says Jan. 20. Data in two studies "did not demonstrate improvement in either reduction or retinal thickness or improvement in visual acuity." While the trials have been halted, Inspire will follow treated patients for one year. The company announced Jan. 30 that it is moving denufosol into Phase III for treatment of cystic fibrosis. Inspire has another P2Y2 agent, diquafosol, which is "approvable" for dry eye (1Pharmaceutical Approvals Monthly December 2005, p. 5)...

Vicuron To File Anidulafungin For Invasive Candidiasis Under Separate NDA

Vicuron’s revised regulatory strategy for anidulafungin involves filing a separate NDA for treatment of invasive candidiasis/candidemia and addressing other concerns through labeling discussions.

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