Drug/indication: Afrezza for diabetes
Approval decision date: Dec. 29, 2010
This is the second review cycle for Afrezza, a small, inhaled insulin device for diabetes.
Drug/indication: Iluvien for diabetic macular edema
Approval decision date: Dec. 30, 2010
Drug/indication: Zictifa for medullary thyroid cancer
Approval decision date: Jan. 7, 2011
An FDA advisory panel on Dec. 2 gave conditional support to the approval of Zictifa, also recommending that a post-approval study be conducted to determine if a lower dose could reduce side effects while maintaining efficacy.
Drug/indication: Vilazodone for major depressive disorder
Approval decision date: Jan. 22, 2011
Drug/indication: Contrave for obesity
Approval decision date: Jan. 31, 2011
An FDA advisory panel held Dec. 7 voted 13-7 to recommend Contrave's approval.
Drug/indication: Yervoy (ipilimumab) for melanoma
FDA advisory panel meeting: Feb. 9, 2011
Approval decision date: March 26, 2011
Both the FDA advisory panel meeting and the FDA's approval decision date for Yervoy were pushed back from December after Bristol submitted additional clinical data. Bristol is seeking initial approval for ipilimumab for patients who have previously received treatment for melanoma.
Drug/indication: Uplyso for Gaucher's disease
Approval decision date: Feb. 25, 2011
Drug/indication: Xiafaxan for irritable bowel syndrome
Approval decision date: March 7, 2011
Xiafaxan is already approved for travelers' diarrhea and hepatic encephalopathy.
Drug/indication: Benlysta for lupus
Approval decision date: March 10, 2011
If approved, Benlysta would be the first new drug for lupus patients in 50 years. GlaxoSmithKline(GSK) will co-market Benlysta. The FDA's approval decision date was pushed back three months from Dec. 9, 2010.
Approval decision date: March 2011
Dendreon is seeking FDA approval to expand Provenge manufacturing capacity at its New Jersey facility. Two additional Provenge plants are under construction outside Atlanta and in Orange Country, Calif. that are expected to come on line in the middle of the year.
Drug/indication: Esbriet for idiopathic pulmonary fibrosis
Approval decision date: First quarter 2011 (estimated)
Intermune is seeking European approval for Esbriet after the FDA rejected the drug in 2010.
Drug/indication: Pixantrone for aggressive non-Hodgkin's lymphoma
Approval decision date: First quarter 2011
Cell Therapeutics filed an appeal with FDA contesting the agency's April 2010 rejection of pixantrone.
Drug/indication: Daxas for chronic obstructive pulmonary disorder
Approval decision date: First quarter 2011
This is the second FDA review cycle for Daxas.
Drug/indication: Horizant for restless leg syndrome
Approval decision date: April 6, 2011
This is the second FDA review cycle for Horizant. The original new drug application was filed to FDA in January 2009.
Drug/indication: Fusilev for colon cancer
Approval decision date: April 29, 2011
This is the second review for Fusilev in colon cancer. The drug is already approved as a treatment for a form of bone cancer.
Drug/indication: ANX-530 for non-small cell lung cancer
Approval decision date: May 3, 2011 (estimated, based on Adventrx's Nov. 3, 2010 filing and assuming a six-month FDA review.)
ANX-530 is a reformulation of the generic chemotherapy drug vinorelbine. The FDA issue a refuse-to-file letter for ANX-530 in 2010.
Drug/indication: Telaprevir for Hepatitis C
Approval decision date: May 23, 2011 (estimated, based on Vertex's filing for approval on Nov. 23, 2010 and assuming six-month FDA review.)
Drug/indication: Hepatic ChemoSat Delivery System for liver metastases in melanoma patients
Approval decision date: June 2011 (estimated, based on expected 2010 year-end filing and a six-month FDA review.)
Drug/indication: brentuximab vedotin for Hodgkin's lymphoma
Approval decision date: Third quarter 2011 (estimated, based on the company's forecast for a first-quarter 2011 approval filing.)
Osiris Therapeutics(OSIR)
Drug/indication: Prochymal for graft-versus-host disease
Status: Prochymal phase III studies failed but Osiris says it plans to meet with FDA "early next year" to determine if Prochymal can still be filed for approval.
Drug/indication: Intermezzo for insomnia
Status: Transcept intends to resubmit Intermezzo to FDA in first quarter 2011 following a complete response letter in October 2009.
Drug/indication: mipomersen for severe hypercholesterolemia
Status: Genzyme is expected to file for mipomersen approval in the first half 2011.
Drug/indication: Levadex for migraines
Status: MAP intends to file for Levadex approval in the first half of 2011.
Drug/indication: lorcaserin for obesity
Status: FDA rejected lorcaserin in October. Arena has not yet disclosed a timetable for resubmitting lorcaserin to FDA.
Drug/indication: Qnexa for obesity
Status: FDA rejected Qnexa in October. Vivus intends to resubmit Qnexa to FDA before the end of 2010.
Drug/indication: Bydureon for diabetes
Status: Additional clinical work required by FDA after October rejection is ongoing. Resubmission expected by end of 2011.
Drug/indication: AZ-004 for agitation in patients with schizophrenia or bipolar disorder
Status: FDA rejected Alexza in October; Alexza still determining a resubmission strategy.
Sources: BioMedTracker, company reports, TheStreet research.
--Written by Adam Feuerstein in Boston.
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1 comment:
Forest Labs has well-established franchises in the therapeutic areas of the central nervous and cardiovascular systems
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