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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All eventsFDA approval (873)PDUFA date (0)Orphan designation (0)Breakthrough therapy (0)Complete response letter (0)Upcoming only·Year:All2015201420132012201120102009200820072006

30 events · 2007

Dec 14
2007
FDA approvalOrphan drug
Thyrogen (Thyrotropin alfa)

For use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of metastatic thyroid cancer

Well-differentiated papillary mesothelial tumour of the pleura· Genzyme Corporation
Dec 13
2007
FDA approvalOrphan drug
Kuvan (sapropterin)

Indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Kuvan is to be used in conjunction with a Phe-restricted diet.

Maternal phenylketonuria syndrome· BioMarin Pharmaceutical, Inc.
Dec 4
2007
label expansion
MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE)FDA label ↗
Laron syndrome with immunodeficiency· GlaxoSmithKline LLC· NDA021078
Nov 16
2007
FDA approvalOrphan drug
Nexavar (sorafenib)

Treatment of unresectable hepatocellular carcinoma

Pediatric hepatocellular carcinoma· Bayer HealthCare Pharmaceuticals, Inc.
Nov 2
2007
label expansion
AMNESTEEM (ISOTRETINOIN)FDA label ↗
· Mylan Pharmaceuticals Inc.· ANDA075945
Nov 2
2007
label expansion
CLARAVIS (ISOTRETINOIN)
· Teva Pharmaceuticals USA, Inc.· ANDA076356
Oct 31
2007
label expansion
AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM)
· Hospira, Inc· ANDA065310
Oct 24
2007
label expansion
VALPROATE SODIUM (VALPROATE SODIUM)
· Sagent Pharmaceuticals· ANDA076295
Sep 23
2007
label expansion
VALPROIC ACID (VALPROIC ACID)
Juvenile absence epilepsy· Bionpharma Inc.· ANDA073484
Aug 30
2007
FDA approvalOrphan drug
Somatuline Depot (Lanreotide)

Long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy

Trichohepatoenteric syndrome· IPSEN, Inc.
Jul 31
2007
FDA approval
ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
· Aurobindo Pharma Limited· ANDA078539
Jul 20
2007
label expansion
SANDIMMUNE (CYCLOSPORINE)
Vernal keratoconjunctivitis· Novartis Pharmaceuticals Corporation· NDA050625
Jul 6
2007
label expansion
ZYPREXA INTRAMUSCULAR (OLANZAPINE)FDA label ↗
· Eli Lilly and Company· NDA021253
Jul 6
2007
label expansion
ZYPREXA ZYDIS (OLANZAPINE)FDA label ↗
· Eli Lilly and Company· NDA021086
Jun 25
2007
label expansion
TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
· Apotex Corp· ANDA071196
Jun 22
2007
label expansion
CARDENE IV (NICARDIPINE HYDROCHLORIDE)FDA label ↗
· Baxter Healthcare Corporation· NDA019734
Jun 15
2007
FDA approvalOrphan drug
Ambrisentan (AMBRISENTAN)

Treatment of pulmonary arterial hypertension (WHO group I) in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening

Pulmonary arterial hypertension· Cipla USA Inc.· ANDA210715
May 31
2007
FDA approvalOrphan drug
Norditropin (SOMATROPIN)FDA label ↗

Treatment of short stature in patients with Noonan syndrome

Progeria-short stature-pigmented nevi syndrome· Novo Nordisk· BLA021148
May 30
2007
FDA approvalOrphan drug
Torisel (Temsirolimus)

Treatment of advanced renal cell carcinoma

Clear cell renal carcinoma· Wyeth Pharmaceuticals, Inc.
May 17
2007
FDA approvalOrphan drug
Doxil (doxorubicin HCL liposome injection)

For use in combination with bortezomib for the treatment of patients with multiple myeloma who have not previously received bortezomib and have at least one prior therapy.

Multiple myeloma· Johnson & Johnson Pharmaceutical Research & Dev.
May 11
2007
label expansion
CARTIA XT (DILTIAZEM HYDROCHLORIDE)
· Actavis Pharma, Inc.· ANDA074752
May 3
2007
FDA approvalOrphan drug
Supprelin LA (Histrelin)

Treatment of central precocious puberty

Rare central precocious puberty· Endo Pharmaceuticals Solutions, Inc.
May 3
2007
label expansion
CONCERTA (METHYLPHENIDATE HYDROCHLORIDE)FDA label ↗
Isolated hyperchlorhidrosis· Janssen Pharmaceuticals, Inc.· NDA021121
Apr 26
2007
FDA approval
FLUOROURACIL (FLUOROURACIL)
· Accord Healthcare, Inc.· ANDA040743
Apr 6
2007
FDA approvalOrphan drug
HepaGam B (hepatitis B immune globulin (human))

Prevention of hepatitis B recurrence following liver transplantation in HBsAG-positive liver transplant patients

Hepatitis B reinfection following liver transplantation· Cangene Corporation
Mar 30
2007
FDA approvalOrphan drug
Ceprotin (Protein C concentrate)

Prevention and treatment of venous thrombosis and purpura fulminans

KIAA1109-related early lethal congenital brain malformations-arthrogryposis syndrome· Baxalta US, Inc.
Feb 6
2007
label expansion
AMNESTEEM (ISOTRETINOIN)
· Mylan Pharmaceuticals Inc.· ANDA075945
Feb 2
2007
label expansion
CLARAVIS (ISOTRETINOIN)
· Teva Pharmaceuticals USA, Inc.· ANDA076356
Jan 31
2007
FDA approvalOrphan drug
Alphanate (Antihemophilic factor (human))

For surgical and/or invasive procedures in patients with von Willebrand Disease (VWD) in whom desmopressin is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery

Pseudo-von Willebrand disease· Grifols Biologicals Inc.
Jan 25
2007
label expansion
CABERGOLINE (CABERGOLINE)
X-linked complex spastic paraplegia· SOLA Pharmaceuticals, LLC· ANDA076310

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.