Treatment Watch

2591 eventsUpdated today

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

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

17 events · FDA approval · 2013

Dec 23
2013
FDA approvalOrphan drug
TRETTEN (coagulation factor XIII A-subunit (recombinant))

Routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency.

Moderate hemophilia A· Novo Nordisk, Inc.
Dec 13
2013
FDA approvalOrphan drug
Kcentra (prothrombin complex concentrate (human))

Urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or need for an urgent surgery/invasive procedure.

Disorder of vitamin and non-protein cofactor absorption and transport· CSL Behring
Nov 22
2013
FDA approvalOrphan drug
Nexavar (sorafenib)

Treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DCT) that is refractory to radioactive iodine treatment.

Adenocarcinoma of the gallbladder and extrahepatic biliary tract· Bayer HealthCare Pharmaceuticals, Inc.
Nov 1
2013
FDA approvalOrphan drug
GAZYVA (obinutuzumab)

GAZYVA, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).

T-cell prolymphocytic leukemia· Genentech Inc., a member of the Roche Group
Oct 18
2013
FDA approvalOrphan drug
Opsumit (macitentan)

Indicated for PAH to delay disease progression. Dual endothelin receptor antagonist.

Pulmonary arterial hypertension· Janssen
Oct 8
2013
FDA approvalOrphan drug
Adempas (riociguat)

Treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) WHO Group 4, after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class

Chronic thromboembolic pulmonary hypertension· Bayer
Sep 6
2013
FDA approvalOrphan drug
Abraxane (paclitaxel protein-bound particles)

Treatment of metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.

Familial atypical multiple mole melanoma syndrome· Abraxis BioScience, LLC
Aug 23
2013
FDA approvalOrphan drug
Valchlor (meclorethamine)

Topical treatment of Stage 1A and 1B mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy.

Classic mycosis fungoides· Helsinn Birex Pharmaceuticals Ltd.
Jun 13
2013
FDA approvalOrphan drug
XGEVA (denosumab)

Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Giant cell tumor of bone· Amgen, Inc.
May 29
2013
FDA approval
MEKINIST (TRAMETINIB)FDA label ↗
Non-small cell lung cancer· Novartis Pharmaceuticals Corporation· NDA204114
May 29
2013
FDA approval
TAFINLAR (DABRAFENIB)FDA label ↗
Malignant lymphoma with peripheral neuropathy· Novartis Pharmaceuticals Corporation· NDA202806
May 17
2013
FDA approvalOrphan drug
IXIARO (Japanese encephalitis vaccine, inactivated, adsorbed)

IXIARO is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus (JEV). IXIARO is approved for use in individuals 2 months of age and older.

Japanese encephalitis· Intercell AG
May 10
2013
FDA approvalOrphan drug
NYMALIZE (nimodipine)

Improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V).

Acquired aneurysmal subarachnoid hemorrhage· Arbor Pharmaceuticals, Inc.
Apr 29
2013
FDA approvalOrphan drug
Actemra (tocilizumab)

ACTEMRA® (tocilizumab) for subcutaneous injection is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older

Rheumatoid factor-positive polyarticular juvenile idiopathic arthritis· Genentech, Inc.
Mar 28
2013
FDA approval
CARBINOXAMINE MALEATE EXTENDED-RELEASE ORAL SUSPENSION (CARBINOXAMINE MALEATE)FDA label ↗
· Neos Therapeutics, LP· NDA022556
Feb 28
2013
FDA approval
ABILIFY MAINTENA (ARIPIPRAZOLE)FDA label ↗
Tourette syndrome· Otsuka America Pharmaceutical, Inc.· NDA202971
Jan 29
2013
FDA approvalOrphan drug
KYNAMRO (mipomersen)

Adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B), total cholesterol (TC), and non-high density lipoprotein-cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).

Homozygous familial hypercholesterolemia· Kastle Therapeutics, LLC

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.