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.
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58 events · 2013

Dec 26
2013
label expansion
TAFINLAR (DABRAFENIB)FDA label ↗
Malignant lymphoma with peripheral neuropathy· Novartis Pharmaceuticals Corporation· NDA202806
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
label expansion
KALYDECO (IVACAFTOR)
Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA203188
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
Dec 12
2013
label expansion
CONCERTA (METHYLPHENIDATE HYDROCHLORIDE)FDA label ↗
Isolated hyperchlorhidrosis· Janssen Pharmaceuticals, Inc.· NDA021121
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 19
2013
label expansion
TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)FDA label ↗
· Apotex Corp· ANDA071196
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 26
2013
label expansion
SABRIL (VIGABATRIN)FDA label ↗
Neuroendocrine tumor of stomach· Lundbeck Pharmaceuticals LLC· NDA020427
Oct 26
2013
label expansion
SABRIL (VIGABATRIN)FDA label ↗
Neuroendocrine tumor of stomach· Lundbeck Pharmaceuticals LLC· NDA022006
Oct 18
2013
FDA approvalOrphan drug
Opsumit (macitentan)

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

Pulmonary arterial hypertension· Janssen
Oct 17
2013
label expansion
PHENTERMINE AND TOPIRAMATE (PHENTERMINE AND TOPIRAMATE)
· Prasco Laboratories· NDA022580
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 30
2013
label expansion
BOSULIF (BOSUTINIB)FDA label ↗
Chronic myeloid leukemia· Pfizer Laboratories Div Pfizer Inc· NDA203341
Sep 27
2013
label expansion
CARDENE IV (NICARDIPINE HYDROCHLORIDE)
· Baxter Healthcare Corporation· NDA019734
Sep 26
2013
label expansion
PUR-WASH (WATER)
Pulmonary arterial hypertension· Niagara Pharmaceuticals Inc.· NDA022305
Sep 24
2013
label expansion
PHENTERMINE AND TOPIRAMATE (PHENTERMINE AND TOPIRAMATE)
· Prasco Laboratories· NDA022580
Sep 24
2013
label expansion
KESIMPTA (OFATUMUMAB)FDA label ↗
T-cell prolymphocytic leukemia· Novartis Pharmaceuticals Corporation· BLA125326
Sep 20
2013
label expansion
USTEKINUMAB (USTEKINUMAB)FDA label ↗
· Janssen Biotech, Inc.· BLA125261
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 30
2013
label expansion
ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
· Onesource Specialty Pharma Limited· ANDA078244
Aug 27
2013
label expansion
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
· Macleods Pharmaceuticals Limited· ANDA202289
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.
Jul 31
2013
label expansion
DEPAKOTE SPRINKLES (DIVALPROEX SODIUM)FDA label ↗
· AbbVie Inc.· NDA019680
Jul 30
2013
label expansion
CONCERTA (METHYLPHENIDATE HYDROCHLORIDE)
Isolated hyperchlorhidrosis· Janssen Pharmaceuticals, Inc.· NDA021121
Jul 26
2013
label expansion
ZYPREXA ZYDIS (OLANZAPINE)FDA label ↗
· Eli Lilly and Company· NDA021086
Jul 25
2013
label expansion
VFEND (VORICONAZOLE)
· Roerig· NDA021267
Jul 25
2013
label expansion
TOPAMAX (TOPIRAMATE)
Lennox-Gastaut syndrome· Janssen Pharmaceuticals, Inc.· NDA020505
Jun 14
2013
label expansion
DEPAKOTE SPRINKLES (DIVALPROEX SODIUM)FDA label ↗
· AbbVie Inc.· NDA019680
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.
Jun 12
2013
label expansion
CONCERTA (METHYLPHENIDATE HYDROCHLORIDE)FDA label ↗
Isolated hyperchlorhidrosis· Janssen Pharmaceuticals, Inc.· NDA021121
Jun 3
2013
label expansion
KALYDECO (IVACAFTOR)
Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA203188
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 23
2013
label expansion
CLOMID (CLOMIPHENE CITRATE)
· Cosette Pharmaceuticals, Inc.· ANDA075528
May 21
2013
label expansion
USTEKINUMAB (USTEKINUMAB)FDA label ↗
· Janssen Biotech, Inc.· BLA125261
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.
May 3
2013
label expansion
SANDIMMUNE (CYCLOSPORINE)FDA label ↗
Vernal keratoconjunctivitis· Novartis Pharmaceuticals Corporation· NDA050625
May 3
2013
label expansion
CONCERTA (METHYLPHENIDATE HYDROCHLORIDE)FDA label ↗
Isolated hyperchlorhidrosis· Janssen Pharmaceuticals, Inc.· NDA021121
May 2
2013
label expansion
CARDENE IV (NICARDIPINE HYDROCHLORIDE)
· Baxter Healthcare Corporation· NDA019734
Apr 30
2013
label expansion
TYVASO (TREPROSTINIL)FDA label ↗
Pulmonary arterial hypertension· United Therapeutics Corporation· NDA022387
Apr 29
2013
label expansion
USTEKINUMAB (USTEKINUMAB)FDA label ↗
· Janssen Biotech, Inc.· BLA125261
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.
Apr 19
2013
label expansion
ATELVIA (RISEDRONATE SODIUM)FDA label ↗
· Allergan, Inc.· NDA022560
Apr 16
2013
label expansion
PHENTERMINE AND TOPIRAMATE (PHENTERMINE AND TOPIRAMATE)FDA label ↗
· Prasco Laboratories· NDA022580
Mar 28
2013
FDA approval
CARBINOXAMINE MALEATE EXTENDED-RELEASE ORAL SUSPENSION (CARBINOXAMINE MALEATE)FDA label ↗
· Neos Therapeutics, LP· NDA022556
Mar 27
2013
label expansion
ZYPREXA RELPREVV (OLANZAPINE PAMOATE)FDA label ↗
· H2-Pharma LLC· NDA022173
Mar 19
2013
label expansion
PHENTERMINE AND TOPIRAMATE (PHENTERMINE AND TOPIRAMATE)FDA label ↗
· Prasco Laboratories· NDA022580
Feb 28
2013
FDA approval
ABILIFY MAINTENA (ARIPIPRAZOLE)FDA label ↗
Tourette syndrome· Otsuka America Pharmaceutical, Inc.· NDA202971
Feb 27
2013
label expansion
MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE)FDA label ↗
Laron syndrome with immunodeficiency· GlaxoSmithKline LLC· NDA021078
Feb 27
2013
label expansion
DEPAKOTE SPRINKLES (DIVALPROEX SODIUM)FDA label ↗
· AbbVie Inc.· NDA019680
Feb 21
2013
label expansion
AMPICILLIN AND SULBACTAM (AMPICILLIN AND SULBACTAM)
· Hikma Pharmaceuticals USA Inc.· ANDA065406
Feb 19
2013
label expansion
CLOMID (CLOMIPHENE CITRATE)
· Cosette Pharmaceuticals, Inc.· ANDA075528
Feb 5
2013
label expansion
ALENDRONATE SODIUM (ALENDRONATE SODIUM)
· Aurobindo Pharma Limited· ANDA090124
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
Jan 25
2013
label expansion
USTEKINUMAB (USTEKINUMAB)FDA label ↗
· Janssen Biotech, Inc.· BLA125261
Jan 7
2013
label expansion
TYVASO (TREPROSTINIL)
Pulmonary arterial hypertension· United Therapeutics Corporation· NDA022387

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.