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 events FDA approval (873)PDUFA date (0)Orphan designation (0)Breakthrough therapy (0)Complete response letter (0)Upcoming only·Year:All 2015 2014 2013 2012 2011 2010 2009 2008 2007 2006

14 events · FDA approval · 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.

Nov 16

2007

FDA approvalOrphan drug

Nexavar (sorafenib)

Treatment of unresectable hepatocellular carcinoma

Pediatric hepatocellular carcinoma· Bayer HealthCare Pharmaceuticals, Inc.

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

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 3

2007

FDA approvalOrphan drug

Supprelin LA (Histrelin)

Treatment of central precocious puberty

Rare central precocious puberty· Endo Pharmaceuticals Solutions, Inc.

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

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.

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.