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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29 events · 2008

Dec 18
2008
label expansion
MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE)FDA label ↗
Laron syndrome with immunodeficiency· GlaxoSmithKline LLC· NDA021078
Dec 15
2008
FDA approvalOrphan drug
Mozobil (r) (plerixafor)

To enhance mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma

Rare disorder potentially indicated for hematopoietic stem cell transplant· Genzyme Corporation
Nov 14
2008
FDA approvalOrphan drug
Banzel (rufinamide)

Adjunctive therapy of seizures associated with Lennox-Gastaut syndrome.

Lennox-Gastaut syndrome· Eisai, Inc.
Nov 7
2008
label expansion
CARDENE IV (NICARDIPINE HYDROCHLORIDE)FDA label ↗
· Baxter Healthcare Corporation· NDA019734
Sep 19
2008
FDA approvalOrphan drug
AdreView (Iobenguane I 123)

To be used in the detection of primary or metastatic pheochromocytomas or neuroblastomas as an adjunct to other diagnostic tests

Esthesioneuroblastoma· GE Healthcare, Inc.
Sep 12
2008
FDA approvalOrphan drug
Gamunex-C (Immune Globulin (Human))

Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse

Chronic inflammatory demyelinating polyneuropathy· Grifols Therapeutics, Inc.
Aug 25
2008
label expansion
ESTRING (ESTRADIOL)FDA label ↗
· Pfizer Laboratories Div Pfizer Inc· NDA020472
Aug 22
2008
FDA approvalOrphan drug
Nplate (ROMIPLOSTIM)FDA label ↗

Treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy

Immune thrombocytopenia· Amgen, Inc· BLA125268
Aug 15
2008
FDA approvalOrphan drug
Xenazine (tetrabenazine)

First drug approved by FDA specifically for Huntington disease chorea.

Huntington's Disease· Lundbeck
Aug 14
2008
label expansion
ZYPREXA INTRAMUSCULAR (OLANZAPINE)FDA label ↗
· Eli Lilly and Company· NDA021253
Aug 14
2008
label expansion
ZYPREXA ZYDIS (OLANZAPINE)FDA label ↗
· Eli Lilly and Company· NDA021086
Aug 11
2008
label expansion
TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
· Apotex Corp· ANDA071196
Aug 8
2008
FDA approval
AK-FLUOR (FLUORESCEIN)FDA label ↗
· Long Grove Pharmaceuticals, LLC· NDA022186
Aug 4
2008
FDA approval
ALENDRONATE SODIUM (ALENDRONATE SODIUM)
· Aurobindo Pharma Limited· ANDA090124
Jul 31
2008
label expansion
CARDENE IV (NICARDIPINE HYDROCHLORIDE)FDA label ↗
· Baxter Healthcare Corporation· NDA019734
Jul 28
2008
label expansion
CARBAMAZEPINE (CARBAMAZEPINE)
Fetal carbamazepine syndrome· Apotex Corp.· ANDA075948
Jun 27
2008
label expansion
CONCERTA (METHYLPHENIDATE HYDROCHLORIDE)FDA label ↗
Isolated hyperchlorhidrosis· Janssen Pharmaceuticals, Inc.· NDA021121
Jun 4
2008
label expansion
CABERGOLINE (CABERGOLINE)
X-linked complex spastic paraplegia· SOLA Pharmaceuticals, LLC· ANDA076310
May 30
2008
label expansion
VFEND (VORICONAZOLE)FDA label ↗
· Roerig· NDA021267
May 7
2008
label expansion
MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE)FDA label ↗
Laron syndrome with immunodeficiency· GlaxoSmithKline LLC· NDA021078
Apr 23
2008
FDA approval
ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
· Onesource Specialty Pharma Limited· ANDA078244
Apr 1
2008
label expansion
VALPROIC ACID (VALPROIC ACID)
Juvenile absence epilepsy· Bionpharma Inc.· ANDA073484
Mar 24
2008
label expansion
DEPAKOTE SPRINKLES (DIVALPROEX SODIUM)
· AbbVie Inc.· NDA019680
Mar 20
2008
FDA approvalOrphan drug
Treanda (Bendamustine hydrochloride)

Treatment of patients with chronic lymphocytic leukemia

T-cell prolymphocytic leukemia· Cephalon, Inc.
Mar 16
2008
label expansion
BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
· Oxford Pharmaceuticals, LLC· ANDA075388
Mar 10
2008
label expansion
VFEND (VORICONAZOLE)FDA label ↗
· Roerig· NDA021267
Feb 27
2008
FDA approval
ARCALYST (RILONACEPT)FDA label ↗
NLRP3-associated autoinflammatory disease· Kiniksa Pharmaceuticals (UK), Ltd.· BLA125249
Feb 27
2008
FDA approvalOrphan drug
Arcalyst (rilonacept)

Treatment of Cryopyrin-Assisted Periodic Syndromes (CAPS)

NLRP3-associated autoinflammatory disease· Kiniksa Pharmaceuticals, Ltd.
Feb 5
2008
label expansion
VFEND (VORICONAZOLE)FDA label ↗
· Roerig· NDA021267

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.