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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All events FDA approval (873)PDUFA date (0)Orphan designation (0)Breakthrough therapy (0)Complete response letter (0)Upcoming only·Year:All 2015 2014 2013 2012 2011 2010 2009 2008 2007 2006

51 events · 2009

Dec 30

2009

label expansion

USTEKINUMAB (USTEKINUMAB)FDA label ↗

· Janssen Biotech, Inc.· BLA125261

Dec 22

2009

label expansion

TOPAMAX (TOPIRAMATE)FDA label ↗

Lennox-Gastaut syndrome· Janssen Pharmaceuticals, Inc.· NDA020844

Dec 22

2009

label expansion

TOPAMAX (TOPIRAMATE)FDA label ↗

Lennox-Gastaut syndrome· Janssen Pharmaceuticals, Inc.· NDA020505

Dec 22

2009

FDA approval

AMPICILLIN AND SULBACTAM (AMPICILLIN AND SULBACTAM)

· Hikma Pharmaceuticals USA Inc.· ANDA065406

Dec 11

2009

FDA approval

ZYPREXA RELPREVV (OLANZAPINE PAMOATE)FDA label ↗

· H2-Pharma LLC· NDA022173

Dec 4

2009

FDA approvalOrphan drug

Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human))

Treatment of spontaneous or trauma-induced bleeding episodes in patients with severe von Willebrand disease (VWD) as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated

Hematological disease associated with an acquired peripheral neuropathy· Octapharma USA, Inc.

Nov 25

2009

label expansion

CARBAMAZEPINE (CARBAMAZEPINE)

Fetal carbamazepine syndrome· Apotex Corp.· ANDA075948

Nov 16

2009

FDA approvalOrphan drug

Qutenza (capsaicin)

Management of neuropathic pain associated with postherpetic neuralgia

Post-herpetic neuralgia· Averitas Pharma, Inc.

Nov 4

2009

label expansion

CONCERTA (METHYLPHENIDATE HYDROCHLORIDE)FDA label ↗

Isolated hyperchlorhidrosis· Janssen Pharmaceuticals, Inc.· NDA021121

Oct 26

2009

FDA approvalOrphan drug

ARZERRA (ofatumumab)

Treatment of chronic lymphocytic leukemia (CLL) refractory to alemtuzumab and fludarabine

T-cell prolymphocytic leukemia· Novartis Pharmaceuticals Corporation

Oct 26

2009

FDA approval

KESIMPTA (OFATUMUMAB)FDA label ↗

T-cell prolymphocytic leukemia· Novartis Pharmaceuticals Corporation· BLA125326

Oct 8

2009

label expansion

SANDIMMUNE (CYCLOSPORINE)FDA label ↗

Vernal keratoconjunctivitis· Novartis Pharmaceuticals Corporation· NDA050625

Oct 8

2009

FDA approvalOrphan drug

Berinert (C1 esterase inhibitor (human))

Treatment of acute attacks of hereditary angioedema.

Renin-angiotensin-aldosterone system-blocker-induced angioedema· CSL Behring LLC

Sep 25

2009

FDA approval

USTEKINUMAB (USTEKINUMAB)FDA label ↗

· Janssen Biotech, Inc.· BLA125261

Sep 24

2009

FDA approvalOrphan drug

Folotyn (pralatrexate)

Treatment of patients with relapsed or refractory peripheral T-cell lymphoma

Extranodal nasal NK/T cell lymphoma· Acrotech Biopharma LLC

Sep 22

2009

label expansion

LAMOTRIGINE (LAMOTRIGINE)

Lennox-Gastaut syndrome· Aurobindo Pharma Limited· ANDA078956

Sep 21

2009

label expansion

LAMOTRIGINE KIT (LAMOTRIGINE)

Lennox-Gastaut syndrome· OWP Pharmaceuticals, Inc.· ANDA078947

Sep 15

2009

FDA approvalOrphan drug

Zirgan (ganciclovir)

Treatment of acute herpetic keratitis (dendritic ulcers)

Transient infantile hypertriglyceridemia and hepatosteatosis· Sirion Therapeutics, Inc.

Sep 4

2009

label expansion

REGLAN (METOCLOPRAMIDE HYDROCHLORIDE)FDA label ↗

· ANI Pharmaceuticals, Inc.· NDA017854

Sep 2

2009

label expansion

MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE)FDA label ↗

Laron syndrome with immunodeficiency· GlaxoSmithKline LLC· NDA021078

Aug 31

2009

label expansion

ZYPREXA INTRAMUSCULAR (OLANZAPINE)FDA label ↗

· Eli Lilly and Company· NDA021253

Aug 31

2009

label expansion

ZYPREXA ZYDIS (OLANZAPINE)FDA label ↗

· Eli Lilly and Company· NDA021086

Aug 21

2009

FDA approval

SABRIL (VIGABATRIN)FDA label ↗

Neuroendocrine tumor of stomach· Lundbeck Pharmaceuticals LLC· NDA020427

Aug 21

2009

FDA approval

VIGABATRIN (VIGABATRIN)

For infantile spasms (IS) - 1 month to 2 years of age.

Cryptogenic late-onset epileptic spasms· Hikma Pharmaceuticals USA Inc

Aug 21

2009

FDA approval

SABRIL (VIGABATRIN)FDA label ↗

Neuroendocrine tumor of stomach· Lundbeck Pharmaceuticals LLC· NDA022006

Aug 20

2009

label expansion

LEVETIRACETAM SOLUTION (LEVETIRACETAM)

· Chartwell RX, LLC· ANDA090263

Jul 30

2009

FDA approvalOrphan drug

Tyvaso (treprostinil)

Indicated to improve exercise ability in PAH patients. Prostacyclin analog.

Pulmonary arterial hypertension· United Therapeutics

Jul 30

2009

FDA approval

TYVASO (TREPROSTINIL)FDA label ↗

Pulmonary arterial hypertension· United Therapeutics Corporation· NDA022387

Jul 29

2009

FDA approvalOrphan drug

Colcrys (colchicine)

Treatment of familial Mediterranean fever

Familial Mediterranean fever· AR Holding Company, Inc.

Jul 2

2009

FDA approvalOrphan drug

So-Aqueous (sotalol (IV))

For use as a substitute for oral sotalol in patients who are unable to take sotalol orally [oral sotalol is indicated for maintenance of normal sinus rhythm in patients with history of highly symptomatic atrial fibrillation /flutter, and for treatment of documented life-threatening ventricular arrhythmias]

Catecholaminergic polymorphic ventricular tachycardia· AltaThera Pharmaceuticals LLC

Jun 30

2009

label expansion

REGLAN (METOCLOPRAMIDE HYDROCHLORIDE)FDA label ↗

· ANI Pharmaceuticals, Inc.· NDA017854

Jun 17

2009

FDA approval

OZURDEX (DEXAMETHASONE)FDA label ↗

Multiple myeloma· Allergan, Inc.· NDA022315

May 22

2009

FDA approvalOrphan drug

Tadalafil (TADALAFIL)

Treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability

Pulmonary arterial hypertension· Northwind Health Company, LLC· ANDA206286

Apr 23

2009

label expansion

TOPAMAX (TOPIRAMATE)FDA label ↗

Lennox-Gastaut syndrome· Janssen Pharmaceuticals, Inc.· NDA020844

Apr 23

2009

label expansion

TOPAMAX (TOPIRAMATE)FDA label ↗

Lennox-Gastaut syndrome· Janssen Pharmaceuticals, Inc.· NDA020505

Apr 23

2009

label expansion

DEPAKOTE SPRINKLES (DIVALPROEX SODIUM)FDA label ↗

· AbbVie Inc.· NDA019680

Apr 22

2009

label expansion

TOPAMAX (TOPIRAMATE)FDA label ↗

Lennox-Gastaut syndrome· Janssen Pharmaceuticals, Inc.· NDA020844

Apr 22

2009

label expansion

TOPAMAX (TOPIRAMATE)FDA label ↗

Lennox-Gastaut syndrome· Janssen Pharmaceuticals, Inc.· NDA020505

Apr 7

2009

FDA approvalOrphan drug

Coartem (artemether/lumefantrine)

Treatment of malaria in patients of 5 kg bodyweight or above with acute, uncomplicated malaria due to Plasmodium falciparum or mixed infections including P. falciparum

Recurrent Neisseria infections due to factor D deficiency· Novartis Pharmaceuticals

Apr 3

2009

FDA approval

LEVETIRACETAM SOLUTION (LEVETIRACETAM)

· Chartwell RX, LLC· ANDA090263

Mar 25

2009

label expansion

LAMOTRIGINE (LAMOTRIGINE)

Lennox-Gastaut syndrome· Sun Pharmaceutical Industries, Inc.· ANDA078525

Mar 19

2009

label expansion

ZYPREXA ZYDIS (OLANZAPINE)FDA label ↗

· Eli Lilly and Company· NDA021086

Feb 25

2009

label expansion

FOAMING HAND WASH (CHLORHEXIDINE GLUCONATE)FDA label ↗

· Medline Industries, LP· NDA019422

Feb 20

2009

FDA approvalOrphan drug

MembraneBlue (Trypan blue)

For use as an aid in ophthalmic surgery by staining the epiretinal membranes during ophthalmic surgical vitrectomy procedures, facilitating removal of the tissue

Retinal degeneration-nanophthalmos-glaucoma syndrome· Dutch Ophthalmic Research Center International BV

Feb 19

2009

label expansion

ALENDRONATE SODIUM (ALENDRONATE SODIUM)

· Aurobindo Pharma Limited· ANDA090124

Feb 6

2009

FDA approvalOrphan drug

ATryn (recombinant human antithrombin)

Prevention of peri-operative and peri-partum thromboembolic events, in hereditary antithrombin deficient patients.

Congenital cataract-progressive muscular hypotonia-hearing loss-developmental delay syndrome· GTC Biotherapeutics, Inc.