Treatment Watch

2591 eventsUpdated today

FDA drug approvals, PDUFA decisions, orphan designations, and breakthrough therapy designations for rare diseases — sourced daily from FDA.gov.

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FDA data is sourced from FDA.gov and openFDA.
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All eventsFDA approval (873)PDUFA date (0)Orphan designation (0)Breakthrough therapy (0)Complete response letter (0)Upcoming only·Year:All2015201420132012201120102009200820072006

12 events · FDA approval · 2008

Dec 15
2008
FDA approvalOrphan drug
Mozobil (r) (plerixafor)

To enhance mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma

Rare disorder potentially indicated for hematopoietic stem cell transplant· Genzyme Corporation
Nov 14
2008
FDA approvalOrphan drug
Banzel (rufinamide)

Adjunctive therapy of seizures associated with Lennox-Gastaut syndrome.

Lennox-Gastaut syndrome· Eisai, Inc.
Sep 19
2008
FDA approvalOrphan drug
AdreView (Iobenguane I 123)

To be used in the detection of primary or metastatic pheochromocytomas or neuroblastomas as an adjunct to other diagnostic tests

Esthesioneuroblastoma· GE Healthcare, Inc.
Sep 12
2008
FDA approvalOrphan drug
Gamunex-C (Immune Globulin (Human))

Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse

Chronic inflammatory demyelinating polyneuropathy· Grifols Therapeutics, Inc.
Aug 22
2008
FDA approvalOrphan drug
Nplate (ROMIPLOSTIM)FDA label ↗

Treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy

Immune thrombocytopenia· Amgen, Inc· BLA125268
Aug 15
2008
FDA approvalOrphan drug
Xenazine (tetrabenazine)

First drug approved by FDA specifically for Huntington disease chorea.

Huntington's Disease· Lundbeck
Aug 8
2008
FDA approval
AK-FLUOR (FLUORESCEIN)FDA label ↗
· Long Grove Pharmaceuticals, LLC· NDA022186
Aug 4
2008
FDA approval
ALENDRONATE SODIUM (ALENDRONATE SODIUM)
· Aurobindo Pharma Limited· ANDA090124
Apr 23
2008
FDA approval
ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
· Onesource Specialty Pharma Limited· ANDA078244
Mar 20
2008
FDA approvalOrphan drug
Treanda (Bendamustine hydrochloride)

Treatment of patients with chronic lymphocytic leukemia

T-cell prolymphocytic leukemia· Cephalon, Inc.
Feb 27
2008
FDA approvalOrphan drug
Arcalyst (rilonacept)

Treatment of Cryopyrin-Assisted Periodic Syndromes (CAPS)

NLRP3-associated autoinflammatory disease· Kiniksa Pharmaceuticals, Ltd.
Feb 27
2008
FDA approval
ARCALYST (RILONACEPT)FDA label ↗
NLRP3-associated autoinflammatory disease· Kiniksa Pharmaceuticals (UK), Ltd.· BLA125249

Not medical advice — always consult your healthcare provider before making treatment decisions.

Data sourced from FDA.gov and openFDA, updated daily. Dates are subject to change. Always verify with FDA.gov for official decisions.