Baxter/Halozyme Hyaluronidase Enhanze SC Set For Approval By September
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Halozyme human-derived hyaluronidase Enhanze SC user fee goal is September 23 following March 23 NDA submission for use as spreading agent. Firm is highlighting greater purity than animal-derived hyaluronidase products. Baxter to market product, provide fill/finish services
You may also be interested in...
Approvals In Brief
GSK Arranon to launch in early 2006: GlaxoSmithKline's leukemia and lymphoma therapy Arranon (nelarabine) will debut early next year following accelerated approval Oct. 28. The orphan drug is indicated for "treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens." Approval of the "last resort" chemotherapy was based on two open-label, single-arm Phase II trials that showed complete disappearance of cancer cells in nine (23%) of the 39 pediatric patients treated and six (21%) of the 28 adults studied, FDA says. Complete disappearance of cancer cells lasted from 3.3 to 9.3 weeks in pediatric patients and from 4 to 195 weeks in adults. GSK will conduct a Phase III confirmatory study to fulfill its accelerated approval requirement...
Vitrase Gains New Molecular Entity Status Due To Lack Of Characterization
NME or not NME? FDA’s question is whether Vitrase is the same as previously approved hyaluronidase. Agency concludes activity shown by USP test supports approval for 505(b)(2) NDA; lack of characterization qualifies Ista’s ovine hyaluronidase for five years of exclusivity
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