|
Exclusivity Start Date
|
Generic Name
|
Trade Name
|
Indication for Original Approvala
|
|
6/10/04
|
Glutamine
|
Nutrestore
|
Treatment of short bowel syndrome in patients receiving specialized nutritional support when used in conjunction with a recombinant human growth hormone that is approved for this indication
|
|
8/12/05
|
Quinine sulfate
|
Qualaquin
|
Treatment of uncomplicated Plasmodium falciparum malaria
|
|
10/28/05
|
Nelarabinec,d
|
Arranon
|
Treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens
|
|
11/2/05
|
Deferasirox
|
Exjade
|
Treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age or older
|
|
12/20/05
|
Sorafenib
|
Nexavar
|
Treatment of patients with advanced renal cell carcinoma
|
|
12/27/05
|
Lenalidomide
|
Revlimid
|
Treatment of patients with transfusion dependant anemia due to low or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5 q cytogenetic abnormality with or without additional cytogenetic abnormalities
|
|
3/1/06
|
Cetuximabc,d,e
|
Erbitux
|
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
|
|
3/29/06
|
Tacrolimusb,c
|
Prograf
|
Prophylaxis of organ rejection in patients receiving allogenic heart transplants
|
|
4/28/06
|
Recombinant human acid alpha-glucosidasec,e
|
Myozyme
|
For use in patients with Pompe disease (GAA deficiency)
|
|
5/2/06
|
Decitabinec
|
Dacogen
|
For treatment of patients with myelodysplastic syndromes
|