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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FDA data is sourced from FDA.gov and openFDA.
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48 events · 2011

Dec 20
2011
FDA approval
AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM)
· NorthStar Rx LLC· ANDA201090
Nov 18
2011
FDA approvalOrphan drug
Erwinase (Erwinia L-asparaginase)

Treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.

Acute lymphoblastic leukemia· Jazz Pharmaceuticals, Inc.
Nov 16
2011
label expansion
VFEND (VORICONAZOLE)FDA label ↗
· Roerig· NDA021267
Nov 4
2011
label expansion
CARBAMAZEPINE (CARBAMAZEPINE)
Fetal carbamazepine syndrome· Apotex Corp.· ANDA075948
Oct 28
2011
label expansion
CARTIA XT (DILTIAZEM HYDROCHLORIDE)
· Actavis Pharma, Inc.· ANDA074752
Oct 26
2011
label expansion
CABERGOLINE (CABERGOLINE)
X-linked complex spastic paraplegia· SOLA Pharmaceuticals, LLC· ANDA076310
Oct 21
2011
FDA approvalOrphan drug
Onfi (clobazam)

Adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome inpatients 2 years of age or older

Lennox-Gastaut syndrome· Lundbeck, Inc.
Oct 17
2011
label expansion
ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
· Aurobindo Pharma Limited· ANDA078539
Oct 7
2011
label expansion
DEPAKOTE SPRINKLES (DIVALPROEX SODIUM)FDA label ↗
· AbbVie Inc.· NDA019680
Sep 29
2011
label expansion
LAMOTRIGINE (LAMOTRIGINE)
Lennox-Gastaut syndrome· Sun Pharmaceutical Industries, Inc.· ANDA078525
Sep 29
2011
label expansion
LAMOTRIGINE KIT (LAMOTRIGINE)
Lennox-Gastaut syndrome· OWP Pharmaceuticals, Inc.· ANDA078947
Sep 23
2011
FDA approvalOrphan drug
SOLIRIS (ECULIZUMAB)

For the treatment of atypical Hemolytic Uremic Syndrome (aHUS)

Atypical hemolytic uremic syndrome· Alexion Pharmaceuticals Inc.
Sep 23
2011
FDA approvalOrphan drug
Remicade (infliximab)

For reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy

Ulcerative colitis· Janssen Biotech, Inc.
Sep 22
2011
label expansion
REGLAN (METOCLOPRAMIDE HYDROCHLORIDE)FDA label ↗
· ANI Pharmaceuticals, Inc.· NDA017854
Sep 20
2011
label expansion
KESIMPTA (OFATUMUMAB)FDA label ↗
T-cell prolymphocytic leukemia· Novartis Pharmaceuticals Corporation· BLA125326
Sep 1
2011
FDA approval
PUR-WASH (WATER)FDA label ↗
Pulmonary arterial hypertension· Niagara Pharmaceuticals Inc.· NDA022305
Aug 22
2011
label expansion
ATELVIA (RISEDRONATE SODIUM)FDA label ↗
· Allergan, Inc.· NDA022560
Aug 19
2011
FDA approvalOrphan drug
Adcetris (brentuximab vedotin)

The treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen

Primary cutaneous peripheral T-cell lymphoma not otherwise specified· Seagen Inc.
Aug 4
2011
FDA approvalOrphan drug
Anascorp (Centruroides immune F(ab)2)

Treatment of clinical signs of scorpion envenomation

Scorpion envenomation· Rare Disease Therapeutics, Inc.
Aug 2
2011
label expansion
REGLAN (METOCLOPRAMIDE HYDROCHLORIDE)FDA label ↗
· ANI Pharmaceuticals, Inc.· NDA017854
Jul 15
2011
label expansion
TOPAMAX (TOPIRAMATE)FDA label ↗
Lennox-Gastaut syndrome· Janssen Pharmaceuticals, Inc.· NDA020844
Jul 15
2011
label expansion
TOPAMAX (TOPIRAMATE)FDA label ↗
Lennox-Gastaut syndrome· Janssen Pharmaceuticals, Inc.· NDA020505
Jun 27
2011
label expansion
TOPAMAX (TOPIRAMATE)
Lennox-Gastaut syndrome· Janssen Pharmaceuticals, Inc.· NDA020844
Jun 27
2011
label expansion
TOPAMAX (TOPIRAMATE)
Lennox-Gastaut syndrome· Janssen Pharmaceuticals, Inc.· NDA020505
Jun 24
2011
label expansion
GABAPENTIN (GABAPENTIN)
Post-herpetic neuralgia· Actavis Pharma, Inc.· ANDA075350
Jun 21
2011
label expansion
ZYPREXA ZYDIS (OLANZAPINE)FDA label ↗
· Eli Lilly and Company· NDA021086
Jun 16
2011
FDA approvalOrphan drug
Istodax (romidepsin)

Treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy

T-cell non-Hodgkin lymphoma· Celgene Corporation
Jun 15
2011
FDA approvalOrphan drug
Nulojix (belatacept)

Prophylaxis of organ rejection in adult patients receiving kidney transplants

MiT family translocation renal cell carcinoma· Bristol-Myers Squibb Company
Jun 1
2011
label expansion
VFEND (VORICONAZOLE)FDA label ↗
· Roerig· NDA021267
Apr 29
2011
FDA approvalOrphan drug
Fusilev (levoleucovorin)

For use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer

Well-differentiated fetal adenocarcinoma of the lung· Acrotech Biopharma LLC
Apr 6
2011
label expansion
ALENDRONATE SODIUM (ALENDRONATE SODIUM)
· Aurobindo Pharma Limited· ANDA090124
Apr 6
2011
FDA approvalOrphan drug
CAPRELSA(r) (vandetanib)

Treatment of asymptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease

Deafness with labyrinthine aplasia, microtia, and microdontia· Genzyme Corporation
Mar 30
2011
label expansion
LAMOTRIGINE (LAMOTRIGINE)
Lennox-Gastaut syndrome· Aurobindo Pharma Limited· ANDA078956
Mar 29
2011
FDA approvalOrphan drug
Sylatron (peginterferon alfa-2b)

Adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy

Malignant melanoma of the mucosa· Merck, Sharpe & Dohme Corp.
Mar 4
2011
label expansion
TOPAMAX (TOPIRAMATE)FDA label ↗
Lennox-Gastaut syndrome· Janssen Pharmaceuticals, Inc.· NDA020844
Mar 4
2011
label expansion
TOPAMAX (TOPIRAMATE)FDA label ↗
Lennox-Gastaut syndrome· Janssen Pharmaceuticals, Inc.· NDA020505
Feb 17
2011
FDA approvalOrphan drug
Corifact (factor XIII concentrate (human))

For the routine prophylactic treatment of congenital factor XIII deficiency

Moderate hemophilia A· CSL Behring LLC
Feb 15
2011
label expansion
ALENDRONATE SODIUM (ALENDRONATE SODIUM)
· Aurobindo Pharma Limited· ANDA090124
Feb 8
2011
label expansion
TYVASO (TREPROSTINIL)FDA label ↗
Pulmonary arterial hypertension· United Therapeutics Corporation· NDA022387
Feb 7
2011
label expansion
CARDENE IV (NICARDIPINE HYDROCHLORIDE)FDA label ↗
· Baxter Healthcare Corporation· NDA019734
Jan 28
2011
FDA approvalOrphan drug
Gralise (gabapentin)

For the management of postherpetic neuralgia

Post-herpetic neuralgia· Golf Acquiror LLC
Jan 25
2011
label expansion
ATELVIA (RISEDRONATE SODIUM)FDA label ↗
· Allergan, Inc.· NDA022560
Jan 25
2011
label expansion
VALPROIC ACID (VALPROIC ACID)
Juvenile absence epilepsy· Bionpharma Inc.· ANDA073484
Jan 18
2011
label expansion
SABRIL (VIGABATRIN)FDA label ↗
Neuroendocrine tumor of stomach· Lundbeck Pharmaceuticals LLC· NDA020427
Jan 18
2011
label expansion
SABRIL (VIGABATRIN)FDA label ↗
Neuroendocrine tumor of stomach· Lundbeck Pharmaceuticals LLC· NDA022006
Jan 14
2011
FDA approvalOrphan drug
Nithiodote (sodium nitrite and sodium thiosulfate)

For sequential use for the treatment of cyanide poisoning that is judged to be life-threatening

Cyanide poisoning· Hope Pharmaceuticals
Jan 13
2011
FDA approval
LAMOTRIGINE (LAMOTRIGINE)FDA label ↗
Lennox-Gastaut syndrome· Alembic Pharmaceuticals Limited· ANDA090607
Jan 4
2011
label expansion
ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
· Aurobindo Pharma Limited· ANDA078539

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.