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12:00 AM
Jan 12, 2009
 |  BioCentury  |  Finance

Approval watch

Approval watch

Selected products up for approval in 2009. (A) Endo (NASDAQ:ENDP) is acquiringIndevus (NASDAQ:IDEV); (B) FDA missed Sept. 26, 2008 PDUFA date; (C) For Myozyme alglucosidase produced at the 2,000 liter bioreactor scale; (D) In September 2008, NovoNordisk (CSE:NVO; NYSE:NVO) said FDA would likely need to extend the March 23, 2009 PDUFA date by a couple of months

Company Product Indication Event Milestone
Abbott (NYSE:ABT)/Takeda (Tokyo:4502) TAK-390MR Gastroesophageal reflux disease (GERD) PDUFA date January
Acusphere (NASDAQ:ACUS)/ Nycomed Imagify perflubutane Coronary heart disease (CAD) PDUFA date 2/28/09
Amgen (NASDAQ:AMGN) Denosumab (AMG 162) Treat/prevent postmenopausal osteoporosis in women and to treat/ prevent bone loss in patients undergoing hormone ablation for prostate or breast cancer

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