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

9 events · FDA approval · 2006

Dec 20
2006
FDA approvalOrphan drug
Colazal (Balsalazide disodium)

Treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Safety and Effectiveness of Colazal beyond 8 weeks in children (ages 5-17) and 12 weeks in adults have not been established.

Ulcerative colitis· Salix Pharmaceuticals, Inc.
Dec 15
2006
FDA approvalOrphan drug
Cyanokit (Hydroxocobalamin)

Treatment on known or suspected cyanide poisoning

Cyanide poisoning· SERB, S.A.
Oct 6
2006
FDA approvalOrphan drug
Zolinza (vorinostat)

Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistant or recurrent disease on or following two systemic therapies.

T-cell non-Hodgkin lymphoma· Merck & Co., Inc.
Jul 26
2006
FDA approvalOrphan drug
Normocarb HF (bicarbonate infusate)

Use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace water and to correct electrolytes and acid-base imbalances in adults and children

Late-onset retinal degeneration· Dialysis Solutions, Inc.
Jul 25
2006
FDA approval
AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM)
· Hospira, Inc· ANDA065310
May 2
2006
FDA approvalOrphan drug
Decitabine (DECITABINE)

for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups

Myelodysplastic syndrome· BluePoint Laboratories· ANDA212826
Apr 28
2006
FDA approvalOrphan drug
Myozyme (Recombinant human acid alpha-glucosidase; alglucosidase alfa)

Myozyme for use in patients with Pompe disease (GAA deficiency). Alglucosidase alfa has been shown to improve ventilator-free survival in patients with infantile onset Pompe disease as compared to an untreated historical control, whereas use of Alphaglucosidase in patients with other forms of Pompe disease has not been adequately studied to assure safety and efficacy.

Glycogen storage disease due to acid maltase deficiency· Genzyme Corporation
Apr 13
2006
FDA approvalOrphan drug
NeoProfen (Ibuprofen lysine)

For closure of a clinically significant patent ductus arteriosus in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective

Premature closure of the arterial duct· Lundbeck, Inc.
Mar 1
2006
FDA approvalOrphan drug
Erbitux (cetuximab)

For use in combination with radiation therapy, for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) and for use as a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed

Squamous cell carcinoma of liver and intrahepatic biliary tract· ImClone Systems Incorporated

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.