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Schering-Plough Temodar Gets Priority Review For First-Line Glioma

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Schering-Plough’s brain tumor therapy Temodar will receive a priority review for first-line treatment of newly diagnosed, high-grade gliomas, the firm announced Oct. 29.

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Approvals In Brief

Schering-Plough Asmanex approved after seven years: Asmanex (mometasone furoate) will not debut before autumn due to ongoing manufacturing validation, Schering-Plough says. The drug clears FDA March 30 for "the maintenance of treatment of asthma as prophylactic therapy in patients 12 years of age and older and treatment of asthma patients who require oral corticosteroid therapy, where adding Asmanex Twisthaler therapy may reduce or eliminate the need for oral corticosteroids." Schering already markets mometasone in the allergy inhaler Nasonex and in the topical cream Elocon. The Asmanex NDA, submitted in November 1998, was delayed by good manufacturing practice compliance issues...

Allos Efaproxyn "approvable"

Allos' radiation sensitizer Efaproxyn (efaproxiral, RSR-13) is "approvable" May 27 for treatment of brain metastases originating from breast cancer. Approval is contingent upon successful completion of the Phase III ENRICH study. "If the study shows effectiveness in this population (increased survival) using the pre-specified analysis, and the study is otherwise satisfactory, we believe it would, together with the subset result in RT-009, support approval," FDA's letter states. Allos limited the RSR-13 filing to breast cancer after the RT-009 trial showed significance in a subset of patients with breast cancer, but not in the overall population (1Pharmaceutical Approvals Monthly Dec. 1, 2003, p. 6). Allos announced European submission of efaproxiral June 4 for the same indication, under the centralized procedure...

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011





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