March 1, 2010 CardioRenal Drugs Advisory Committee - belatacept injectable (Bristol Myers Squibb) - http://fdaac.com

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March 1, 2010 - Cardiovascular and Renal Drugs Advisory Committee
BLA - belatacept injectable (Bristol Myers Squibb)
Agenda: On March 1, 2010, the committee will discuss biologics license application (BLA) 125288, for belatacept injectable, by Bristol Myers Squibb, to be used in patients with kidney transplants to prevent rejection of the transplanted kidney.

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March 10 & 11, 2010 Pulmonary-Allergy Drugs Advisory Committee - beta-2 adrenergic agonists - http://fdaac.com

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March 10 & 11, 2010 - Pulmonary-Allergy Drugs Advisory Committee
long acting beta-2 adrenergic agonists review
Agenda: On March 10 and 11, 2010, the committee will discuss the design of medical research studies (known as ``clinical trial design'') to evaluate serious asthma outcomes (such as hospitalizations, a procedure using a breathing tube known as intubation, or death) with the use of the class of asthma medications known as long acting beta-2 adrenergic agonists in the treatment of asthma in adults, adolescents, and children.

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March 9, 2010 Pulmonary-Allergy Drugs Advisory Committee - prifenidone (InterMune) - http://fdaac.com

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March 9, 2010 - Pulmonary-Allergy Drugs Advisory Committee
NDA - prifenidone (InterMune)
Agenda: On March 9, 2010, the committee will discuss new drug application (NDA) 22-535, pirfenidone, by InterMune. The proposed indication (purpose) of this drug is the treatment of patients with idiopathic pulmonary fibrosis (scarring of the lungs without a known cause to decrease the decline in lung function associated with this condition.

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February 10, 2010 - Oncologic Drugs Advisory Committee - http://FDAAC.com

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February 10, 2010 - Oncologic Drugs Advisory Committee

NDA - PIXUVRI (Cell Therapeutics)

NDA - OMAPRO (ChemGenex Pharm)

Agenda: On February 10, 2010, during the morning session, the committee will discuss new drug application (NDA) 022-481, proposed trade name PIXUVRI (pixantrone dimaleate) injection, manufactured by Cell Therapeutics, Inc. The proposed indication (use) for this product is as a single agent treatment for patients with recurring or refractory (difficult to treat), aggressive non-Hodgkin’s lymphoma (NHL) who have received two or more prior lines of therapy.

During the afternoon session, the committee will discuss NDA 022-374, proposed trade name OMAPRO (omacetaxine mepesuccinate) for injection, manufactured by ChemGenex Pharmaceuticals. The proposed indication (use) for this product is for the treatment of adults with chronic myeloid leukemia (CML) bearing a genetic alteration known as the Bcr-Abl T315I mutation, and who have failed prior therapy with the drug imatinib.

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