Treatment Watch

2715 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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59 events · 2012

Dec 21
2012
FDA approvalOrphan drug
Kineret (anakinra)

Treatment of neonatal-onset multisystem inflammatory disease (NOMID)

CINCA syndrome· Swedish Orphan Biovitrum AB (publ)
Dec 21
2012
FDA approvalOrphan drug
GATTEX (teduglutide [rDNA origin])

Treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support

Primary short bowel syndrome· Takeda Pharmaceuticals U.S.A., Inc.
Dec 21
2012
FDA approvalOrphan drug
Juxtapid (lomitapide)

Adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).

Homozygous familial hypercholesterolemia· Chiesi Farmaceutici S.p.A.
Dec 20
2012
FDA approvalOrphan drug
VARIZIG (Varicella Zoster Immune Globulin (Human))

Post exposure prophylaxis of varicella in high risk individuals to reduce the severity of varicella

Severe mendelian susceptibility to mycobacterial diseases due to complete IFNG deficiency· Cangene bioPharma, Inc.
Dec 14
2012
FDA approvalOrphan drug
ABthraxTM (raxibacumab)

Treatment of inhalation anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs,

Inhalational anthrax· Human Genome Sciences, Inc.
Dec 14
2012
label expansion
SABRIL (VIGABATRIN)
Neuroendocrine tumor of stomach· Lundbeck Pharmaceuticals LLC· NDA020427
Dec 12
2012
label expansion
FOAMING HAND WASH (CHLORHEXIDINE GLUCONATE)FDA label ↗
· Medline Industries, LP· NDA019422
Dec 11
2012
label expansion
SABRIL (VIGABATRIN)FDA label ↗
Neuroendocrine tumor of stomach· Lundbeck Pharmaceuticals LLC· NDA020427
Dec 11
2012
label expansion
SABRIL (VIGABATRIN)FDA label ↗
Neuroendocrine tumor of stomach· Lundbeck Pharmaceuticals LLC· NDA022006
Nov 1
2012
label expansion
PHENTERMINE AND TOPIRAMATE (PHENTERMINE AND TOPIRAMATE)FDA label ↗
· Prasco Laboratories· NDA022580
Oct 29
2012
label expansion
TOPAMAX (TOPIRAMATE)FDA label ↗
Lennox-Gastaut syndrome· Janssen Pharmaceuticals, Inc.· NDA020844
Oct 29
2012
label expansion
TOPAMAX (TOPIRAMATE)FDA label ↗
Lennox-Gastaut syndrome· Janssen Pharmaceuticals, Inc.· NDA020505
Oct 26
2012
FDA approvalOrphan drug
Synribo (omacetaxine mepesuccinate)

Treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI)

Chronic myeloid leukemia· IVAX International GmbH
Oct 4
2012
label expansion
TRACLEER (BOSENTAN)FDA label ↗
Pulmonary arterial hypertension· Actelion Pharmaceuticals US, Inc.· NDA021290
Oct 2
2012
label expansion
TRACLEER (BOSENTAN)FDA label ↗
Pulmonary arterial hypertension· Actelion Pharmaceuticals US, Inc.· NDA021290
Oct 2
2012
FDA approvalOrphan drug
Cystaran (Cysteamine hydrochloride)

Treatment of corneal cystine crystal accumulation in patients with cystinosis

Adenovirus infection in immunocompromised patients· Leadiant Biosciences, Inc.
Sep 12
2012
FDA approval
AUBAGIO (TERIFLUNOMIDE)FDA label ↗
· Genzyme Corporation· NDA202992
Sep 7
2012
label expansion
OZURDEX (DEXAMETHASONE)FDA label ↗
Multiple myeloma· Allergan, Inc.· NDA022315
Sep 4
2012
FDA approval
BOSULIF (BOSUTINIB)FDA label ↗
Chronic myeloid leukemia· Pfizer Laboratories Div Pfizer Inc· NDA203341
Aug 30
2012
label expansion
SANDIMMUNE (CYCLOSPORINE)FDA label ↗
Vernal keratoconjunctivitis· Novartis Pharmaceuticals Corporation· NDA050625
Aug 28
2012
label expansion
KALYDECO (IVACAFTOR)FDA label ↗
Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA203188
Aug 28
2012
label expansion
GABAPENTIN (GABAPENTIN)
Post-herpetic neuralgia· Actavis Pharma, Inc.· ANDA075350
Aug 13
2012
label expansion
ATELVIA (RISEDRONATE SODIUM)FDA label ↗
· Allergan, Inc.· NDA022560
Aug 13
2012
FDA approvalOrphan drug
Technetium Tc99m Sulfur Colloi (Technetium Tc99m sulfur colloid injection, lyophilized)

Localization of lymph nodes draining a primary tumor in patients with melanoma when used with a hand-held gamma counter

Cholestatic pruritus in patients with Alagille syndrome (ALGS)· Pharmalucence, Inc.
Aug 9
2012
FDA approval
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
· Macleods Pharmaceuticals Limited· ANDA202289
Aug 9
2012
FDA approvalOrphan drug
Marqibo (vinCRIStine sulfate LIPOSOME injection)

Treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies.

Acute lymphoblastic leukemia· Acrotech Biopharma LLC
Aug 3
2012
label expansion
ZYPREXA RELPREVV (OLANZAPINE PAMOATE)FDA label ↗
· H2-Pharma LLC· NDA022173
Jul 19
2012
label expansion
LEVETIRACETAM SOLUTION (LEVETIRACETAM)
· Chartwell RX, LLC· ANDA090263
Jul 17
2012
FDA approval
PHENTERMINE AND TOPIRAMATE (PHENTERMINE AND TOPIRAMATE)FDA label ↗
· Prasco Laboratories· NDA022580
Jun 25
2012
label expansion
ALENDRONATE SODIUM (ALENDRONATE SODIUM)
· Aurobindo Pharma Limited· ANDA090124
Jun 22
2012
FDA approvalOrphan drug
Gammagard Liquid (immune globulin infusion (human))

Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).

Multifocal motor neuropathy· Takeda Pharmaceuticals U.S.A., Inc.
Jun 14
2012
label expansion
USTEKINUMAB (USTEKINUMAB)FDA label ↗
· Janssen Biotech, Inc.· BLA125261
Jun 13
2012
FDA approvalOrphan drug
Durezol (difluprednate)

Treatment of endogenous anterior uveitis

Granulomatous arthritis of childhood· Alcon Pharmaceuticals. Ltd.
Jun 6
2012
FDA approvalOrphan drug
Horizant (gabapentin enacarbil)

Management of postherpetic neuralgia in adults.

Post-herpetic neuralgia· Arbor Pharmaceuticals, LLC
May 31
2012
label expansion
USTEKINUMAB (USTEKINUMAB)FDA label ↗
· Janssen Biotech, Inc.· BLA125261
May 25
2012
FDA approval
ABSORICA (ISOTRETINOIN)FDA label ↗
· Sun Pharmaceutical Industries, Inc.· NDA021951
May 18
2012
label expansion
LAMOTRIGINE (LAMOTRIGINE)
Lennox-Gastaut syndrome· Alembic Pharmaceuticals Limited· ANDA090607
May 17
2012
label expansion
ALENDRONATE SODIUM (ALENDRONATE SODIUM)
· Aurobindo Pharma Limited· ANDA090124
May 2
2012
label expansion
USTEKINUMAB (USTEKINUMAB)FDA label ↗
· Janssen Biotech, Inc.· BLA125261
Apr 30
2012
label expansion
ISOTRETINOIN (ISOTRETINOIN)
· Mayne Pharma· ANDA076485
Apr 26
2012
FDA approvalOrphan drug
Votrient (pazopanib)

Advanced soft tissue sarcoma (STS) who have received prior chemotherapy

Alveolar soft tissue sarcoma· Novartis Pharmaceuticals Corp
Apr 25
2012
label expansion
LAMOTRIGINE (LAMOTRIGINE)
Lennox-Gastaut syndrome· Aurobindo Pharma Limited· ANDA078956
Apr 12
2012
label expansion
AMNESTEEM (ISOTRETINOIN)
· Mylan Pharmaceuticals Inc.· ANDA075945
Apr 12
2012
label expansion
CLARAVIS (ISOTRETINOIN)
· Teva Pharmaceuticals USA, Inc.· ANDA076356
Apr 11
2012
label expansion
GABAPENTIN (GABAPENTIN)
Post-herpetic neuralgia· Actavis Pharma, Inc.· ANDA075350
Apr 6
2012
label expansion
USTEKINUMAB (USTEKINUMAB)FDA label ↗
· Janssen Biotech, Inc.· BLA125261
Mar 30
2012
FDA approval
IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)FDA label ↗
· Teva Pharmaceuticals USA, Inc.· ANDA077369
Mar 19
2012
FDA approval
IBANDRONATE SODIUM (IBANDRONATE SODIUM)
· Apotex Corp· ANDA078948
Mar 15
2012
label expansion
LAMOTRIGINE (LAMOTRIGINE)
Lennox-Gastaut syndrome· Alembic Pharmaceuticals Limited· ANDA090607
Mar 14
2012
label expansion
LAMOTRIGINE (LAMOTRIGINE)
Lennox-Gastaut syndrome· Sun Pharmaceutical Industries, Inc.· ANDA078525
Mar 14
2012
label expansion
LAMOTRIGINE KIT (LAMOTRIGINE)
Lennox-Gastaut syndrome· OWP Pharmaceuticals, Inc.· ANDA078947
Mar 7
2012
label expansion
KETALAR (KETAMINE HYDROCHLORIDE)FDA label ↗
Lethal Larsen-like syndrome· Par Health USA, LLC· NDA016812
Feb 24
2012
label expansion
OZURDEX (DEXAMETHASONE)FDA label ↗
Multiple myeloma· Allergan, Inc.· NDA022315
Feb 17
2012
FDA approvalOrphan drug
Korlym (mifepristone)

for the control of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.

Endogenous Cushing syndrome· Corcept Therapeutics, Inc.
Feb 7
2012
FDA approvalOrphan drug
Mitosol (mitomycin-C)

An adjunct to ab externo glaucoma surgery.

Congenital malformation of the eye with glaucoma as a major feature· Glaukos Corporation
Jan 31
2012
FDA approval
KALYDECO (IVACAFTOR)FDA label ↗
Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA203188
Jan 31
2012
label expansion
LAMOTRIGINE KIT (LAMOTRIGINE)
Lennox-Gastaut syndrome· OWP Pharmaceuticals, Inc.· ANDA078947
Jan 19
2012
FDA approval
ISOTRETINOIN (ISOTRETINOIN)FDA label ↗
· Mayne Pharma· ANDA076485
Jan 17
2012
FDA approvalOrphan drug
Voraxaze (glucarpidase)

Treatment of toxic (>1 micromole/liter) plasma methotrexate concentrations in patients with delayed methotrexate clearance due to impaired renal function.

Methotrexate toxicity· BTG International Inc.

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.