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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27 events · FDA approval · 2009

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 16
2009
FDA approvalOrphan drug
Qutenza (capsaicin)

Management of neuropathic pain associated with postherpetic neuralgia

Post-herpetic neuralgia· Averitas Pharma, Inc.
Oct 26
2009
FDA approval
KESIMPTA (OFATUMUMAB)FDA label ↗
T-cell prolymphocytic leukemia· Novartis Pharmaceuticals Corporation· BLA125326
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 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 15
2009
FDA approvalOrphan drug
Zirgan (ganciclovir)

Treatment of acute herpetic keratitis (dendritic ulcers)

Transient infantile hypertriglyceridemia and hepatosteatosis· Sirion Therapeutics, Inc.
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 21
2009
FDA approval
SABRIL (VIGABATRIN)FDA label ↗
Neuroendocrine tumor of stomach· Lundbeck Pharmaceuticals LLC· NDA020427
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 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 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
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 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.
Jan 27
2009
FDA approval
LAMOTRIGINE KIT (LAMOTRIGINE)
Lennox-Gastaut syndrome· OWP Pharmaceuticals, Inc.· ANDA078947
Jan 27
2009
FDA approval
LAMOTRIGINE (LAMOTRIGINE)
Lennox-Gastaut syndrome· Aurobindo Pharma Limited· ANDA078956
Jan 27
2009
FDA approval
LAMOTRIGINE (LAMOTRIGINE)
Lennox-Gastaut syndrome· Sun Pharmaceutical Industries, Inc.· ANDA078525
Jan 16
2009
FDA approvalOrphan drug
RiaSTAP (human fibrinogen concentrate, pasteurized)

Treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia)

Congenital fibrinogen deficiency· CSL Behring, 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.