Treatment Watch

2591 eventsUpdated today

FDA drug approvals, PDUFA decisions, orphan designations, and breakthrough therapy designations for rare diseases — sourced daily from FDA.gov.

FDA data is sourced from FDA.gov and openFDA.
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All eventsFDA approval (873)PDUFA date (0)Orphan designation (0)Breakthrough therapy (0)Complete response letter (0)Upcoming only·Year:All2015201420132012201120102009200820072006

86 events · 2015

Dec 23
2015
label expansion
ZYPREXA RELPREVV (OLANZAPINE PAMOATE)
· H2-Pharma LLC· NDA022173
Dec 23
2015
label expansion
ABSORICA (ISOTRETINOIN)
· Sun Pharmaceutical Industries, Inc.· NDA021951
Dec 22
2015
FDA approvalOrphan drug
Uptravi (selexipag)

Indicated for PAH to delay disease progression and reduce hospitalization risk.

Pulmonary arterial hypertension· Janssen
Dec 21
2015
label expansion
DUOPA (CARBIDOPA AND LEVODOPA)
Prader-Willi-like syndrome· AbbVie Inc.· NDA203952
Dec 21
2015
label expansion
CARDENE IV (NICARDIPINE HYDROCHLORIDE)
· Baxter Healthcare Corporation· NDA019734
Dec 16
2015
label expansion
AMNESTEEM (ISOTRETINOIN)
· Mylan Pharmaceuticals Inc.· ANDA075945
Dec 7
2015
FDA approvalOrphan drug
Bendeka (bendamustine for 50 ml admixture)

Treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established.

T-cell prolymphocytic leukemia· Eagle Pharmaceuticals, Inc.
Dec 2
2015
label expansion
CARBINOXAMINE MALEATE EXTENDED-RELEASE ORAL SUSPENSION (CARBINOXAMINE MALEATE)
· Neos Therapeutics, LP· NDA022556
Nov 30
2015
label expansion
VALPROIC ACID (VALPROIC ACID)
Juvenile absence epilepsy· Bionpharma Inc.· ANDA073484
Nov 24
2015
label expansion
KALYDECO (IVACAFTOR)
Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA203188
Nov 20
2015
label expansion
TAFINLAR (DABRAFENIB)FDA label ↗
Malignant lymphoma with peripheral neuropathy· Novartis Pharmaceuticals Corporation· NDA202806
Nov 20
2015
FDA approvalOrphan drug
Ninlaro (ixazomib citrate)

Use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy

Multiple myeloma· Takeda Development Center Americas, Inc.
Nov 20
2015
label expansion
MEKINIST (TRAMETINIB)FDA label ↗
Non-small cell lung cancer· Novartis Pharmaceuticals Corporation· NDA204114
Nov 18
2015
FDA approval
NARCAN (NALOXONE HYDROCHLORIDE NASAL)FDA label ↗
· Emergent Devices Inc.· NDA208411
Nov 13
2015
FDA approvalOrphan drug
Tagrisso (osimertinib)

For treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR TKI therapy

Non-small cell lung cancer· AstraZeneca Pharmaceuticals LP
Nov 13
2015
FDA approvalOrphan drug
Neulasta (Pegfilgrastim)

To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome)

Difference of sex development of gynecological interest· Amgen, Inc.
Nov 3
2015
label expansion
SABRIL (VIGABATRIN)FDA label ↗
Neuroendocrine tumor of stomach· Lundbeck Pharmaceuticals LLC· NDA022006
Oct 28
2015
FDA approvalOrphan drug
Yervoy (ipilimumab)

For the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm, who have undergone complete resection including total lymphadenectomy.

Rare parathyroid disease and phosphocalcic metabolism anomaly· Bristol-Myers Squibb Company
Oct 27
2015
FDA approvalOrphan drug
IMLYGIC (talimogene laherparepvec)

Indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery

Melanoma· BioVex, Inc. (subsidiary of Amgen)
Oct 26
2015
label expansion
ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
· Onesource Specialty Pharma Limited· ANDA078244
Oct 23
2015
FDA approvalOrphan drug
Strensiq (ASFOTASE ALFA)FDA label ↗

For the treatment of patients with perinatal/infantile-and juvenile-onset hypophosphatasia (HPP)

Prenatal benign hypophosphatasia· Alexion Pharmaceuticals, Inc.· BLA125513
Oct 23
2015
FDA approvalOrphan drug
Yondelis (trabectedin)

For the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen

Alveolar soft tissue sarcoma· Janssen Research & Development, LLC
Oct 8
2015
label expansion
BOSULIF (BOSUTINIB)
Chronic myeloid leukemia· Pfizer Laboratories Div Pfizer Inc· NDA203341
Sep 29
2015
label expansion
ESTRING (ESTRADIOL)FDA label ↗
· Pfizer Laboratories Div Pfizer Inc· NDA020472
Sep 23
2015
label expansion
DEPAKOTE SPRINKLES (DIVALPROEX SODIUM)FDA label ↗
· AbbVie Inc.· NDA019680
Sep 22
2015
label expansion
BOSULIF (BOSUTINIB)FDA label ↗
Chronic myeloid leukemia· Pfizer Laboratories Div Pfizer Inc· NDA203341
Sep 18
2015
label expansion
SABRIL (VIGABATRIN)FDA label ↗
Neuroendocrine tumor of stomach· Lundbeck Pharmaceuticals LLC· NDA020427
Sep 18
2015
label expansion
SABRIL (VIGABATRIN)FDA label ↗
Neuroendocrine tumor of stomach· Lundbeck Pharmaceuticals LLC· NDA022006
Sep 17
2015
label expansion
ZYPREXA RELPREVV (OLANZAPINE PAMOATE)FDA label ↗
· H2-Pharma LLC· NDA022173
Sep 10
2015
label expansion
CARBINOXAMINE MALEATE EXTENDED-RELEASE ORAL SUSPENSION (CARBINOXAMINE MALEATE)
· Neos Therapeutics, LP· NDA022556
Sep 9
2015
FDA approvalOrphan drug
HUMIRA (adalimumab)

Treatment of moderate to severe hidradenitis suppurativa

Hidradenitis suppurativa· AbbVie, Inc.
Sep 3
2015
label expansion
ISOTRETINOIN (ISOTRETINOIN)
· Mayne Pharma· ANDA076485
Sep 3
2015
label expansion
ABSORICA (ISOTRETINOIN)FDA label ↗
· Sun Pharmaceutical Industries, Inc.· NDA021951
Sep 3
2015
label expansion
AMNESTEEM (ISOTRETINOIN)
· Mylan Pharmaceuticals Inc.· ANDA075945
Sep 3
2015
label expansion
CLARAVIS (ISOTRETINOIN)
· Teva Pharmaceuticals USA, Inc.· ANDA076356
Sep 1
2015
label expansion
KALYDECO (IVACAFTOR)
Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA203188
Aug 27
2015
FDA approvalOrphan drug
Repatha (evolocumab)

As an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with HoFH who require additional lowering of LDL-C.

Homozygous familial hypercholesterolemia· Amgen Inc.
Aug 20
2015
FDA approval
DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE HYDROCHLORIDE)
Combined hyperlipidemia· Sun Pharmaceuticals Industries, Inc.· ANDA202126
Aug 19
2015
FDA approval
IBANDRONATE SODIUM (IBANDRONATE SODIUM)FDA label ↗
· Eugia US LLC· ANDA205332
Aug 12
2015
label expansion
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
· Saptalis Pharmaceuticals, LLC.· ANDA080983
Jul 29
2015
label expansion
ABILIFY MAINTENA (ARIPIPRAZOLE)FDA label ↗
Tourette syndrome· Otsuka America Pharmaceutical, Inc.· NDA202971
Jul 24
2015
label expansion
IBANDRONATE SODIUM (IBANDRONATE SODIUM)
· Apotex Corp· ANDA078948
Jul 23
2015
label expansion
ZYPREXA RELPREVV (OLANZAPINE PAMOATE)FDA label ↗
· H2-Pharma LLC· NDA022173
Jul 23
2015
label expansion
ZYPREXA INTRAMUSCULAR (OLANZAPINE)FDA label ↗
· Eli Lilly and Company· NDA021253
Jul 23
2015
label expansion
ZYPREXA ZYDIS (OLANZAPINE)FDA label ↗
· Eli Lilly and Company· NDA021086
Jul 22
2015
label expansion
ALENDRONATE SODIUM (ALENDRONATE SODIUM)
· Aurobindo Pharma Limited· ANDA090124
Jul 20
2015
label expansion
AK-FLUOR (FLUORESCEIN)
· Long Grove Pharmaceuticals, LLC· NDA022186
Jul 20
2015
label expansion
CLARAVIS (ISOTRETINOIN)
· Teva Pharmaceuticals USA, Inc.· ANDA076356
Jul 13
2015
FDA approvalOrphan drug
Iressa (gefitinib)

For the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test

Non-small cell lung cancer· AstraZeneca Pharmaceuticals LP
Jul 2
2015
FDA approval
ORKAMBI (LUMACAFTOR AND IVACAFTOR)FDA label ↗
Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA206038
Jun 23
2015
label expansion
TYVASO (TREPROSTINIL)
Pulmonary arterial hypertension· United Therapeutics Corporation· NDA022387
Jun 16
2015
label expansion
TOPIRAMATE (TOPIRAMATE)
Lennox-Gastaut syndrome· Upsher-Smith Laboratories, LLC· NDA205122
Jun 15
2015
label expansion
REGLAN (METOCLOPRAMIDE HYDROCHLORIDE)
· ANI Pharmaceuticals, Inc.· NDA017854
Jun 2
2015
label expansion
TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)FDA label ↗
· Apotex Corp· ANDA071196
May 22
2015
label expansion
DUOPA (CARBIDOPA AND LEVODOPA)
Prader-Willi-like syndrome· AbbVie Inc.· NDA203952
May 21
2015
label expansion
CARDENE IV (NICARDIPINE HYDROCHLORIDE)
· Baxter Healthcare Corporation· NDA019734
May 11
2015
label expansion
TOPAMAX (TOPIRAMATE)
Lennox-Gastaut syndrome· Janssen Pharmaceuticals, Inc.· NDA020505
May 6
2015
FDA approvalOrphan drug
Anavip (crotalidae immune F(ab')2 (equine))

Management of adult and pediatric patients with North American rattlesnake envenomation

Envenomization by Bothrops lanceolatus· Rare Disease Therapeutics, Inc.
Apr 17
2015
label expansion
CONCERTA (METHYLPHENIDATE HYDROCHLORIDE)FDA label ↗
Isolated hyperchlorhidrosis· Janssen Pharmaceuticals, Inc.· NDA021121
Apr 17
2015
label expansion
REGLAN (METOCLOPRAMIDE HYDROCHLORIDE)
· ANI Pharmaceuticals, Inc.· NDA017854
Apr 8
2015
label expansion
ATELVIA (RISEDRONATE SODIUM)FDA label ↗
· Allergan, Inc.· NDA022560
Mar 31
2015
label expansion
SANDIMMUNE (CYCLOSPORINE)FDA label ↗
Vernal keratoconjunctivitis· Novartis Pharmaceuticals Corporation· NDA050625
Mar 30
2015
FDA approvalOrphan drug
Neupogen (filgrastim)

To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome).

Difference of sex development of gynecological interest· Amgen, Inc.
Mar 30
2015
label expansion
TOPIRAMATE (TOPIRAMATE)FDA label ↗
Lennox-Gastaut syndrome· Upsher-Smith Laboratories, LLC· NDA205122
Mar 26
2015
label expansion
ATELVIA (RISEDRONATE SODIUM)FDA label ↗
· Allergan, Inc.· NDA022560
Mar 25
2015
label expansion
IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
· Teva Pharmaceuticals USA, Inc.· ANDA077369
Mar 17
2015
FDA approvalOrphan drug
Cholbam (CHOLIC ACID)FDA label ↗

Treatment of bile acid synthesis disorders due to single enzyme defects

Rare inborn errors of metabolism· Mirum Pharmaceuticals Inc.· NDA205750
Mar 16
2015
label expansion
GABAPENTIN (GABAPENTIN)
Post-herpetic neuralgia· Actavis Pharma, Inc.· ANDA075350
Mar 13
2015
label expansion
DEPAKOTE SPRINKLES (DIVALPROEX SODIUM)FDA label ↗
· AbbVie Inc.· NDA019680
Mar 10
2015
FDA approvalOrphan drug
Unituxin (dinutuximab)

For use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy

Esthesioneuroblastoma· United Therapeutics Corporation
Mar 9
2015
label expansion
KALYDECO (IVACAFTOR)
Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA203188
Mar 4
2015
label expansion
KALYDECO (IVACAFTOR)FDA label ↗
Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA203188
Feb 23
2015
FDA approvalOrphan drug
Farydak (panobinostat)

FARYDAK (panobinostat) in combination with bortezomib (BTZ) and dexamethasone (DEX) for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent

Multiple myeloma· zr pharma& GmbH
Feb 18
2015
label expansion
CARBAMAZEPINE (CARBAMAZEPINE)
Fetal carbamazepine syndrome· Apotex Corp.· ANDA075948
Feb 12
2015
label expansion
AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM)
· Hospira, Inc· ANDA065310
Feb 9
2015
label expansion
AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM)
· NorthStar Rx LLC· ANDA201090
Feb 3
2015
label expansion
VFEND (VORICONAZOLE)FDA label ↗
· Roerig· NDA021267
Jan 30
2015
FDA approval
SCOPOLAMINE TRANSDERMAL SYSTEM (SCOPOLAMINE TRANSDERMAL SYSTEM)FDA label ↗
· Padagis Israel Pharmaceuticals Ltd· ANDA078830
Jan 23
2015
FDA approvalOrphan drug
Natpara (parathyroid hormone)

An adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism

Rare hypoparathyroidism· Takeda Pharmaceuticals U.S.A., Inc.
Jan 15
2015
label expansion
ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
· Aurobindo Pharma Limited· ANDA078539
Jan 12
2015
label expansion
REGLAN (METOCLOPRAMIDE HYDROCHLORIDE)
· ANI Pharmaceuticals, Inc.· NDA017854
Jan 9
2015
FDA approval
DUOPA (CARBIDOPA AND LEVODOPA)FDA label ↗
Prader-Willi-like syndrome· AbbVie Inc.· NDA203952
Jan 7
2015
label expansion
PUR-WASH (WATER)
Pulmonary arterial hypertension· Niagara Pharmaceuticals Inc.· NDA022305
Jan 7
2015
label expansion
DEPAKOTE SPRINKLES (DIVALPROEX SODIUM)FDA label ↗
· AbbVie Inc.· NDA019680
Jan 5
2015
label expansion
KALYDECO (IVACAFTOR)
Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA203188
Jan 5
2015
label expansion
ABILIFY MAINTENA (ARIPIPRAZOLE)
Tourette syndrome· Otsuka America Pharmaceutical, Inc.· NDA202971

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.