Exclusivity Start Date

Generic Name

Trade Name

Indication for Original Approvala

6/28/06

Dasatinibd

Sprycel

(1) Treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy. (2) Treatment of adults with CML with resistance or intolerance to prior therapy including imatinib.

7/24/06

Idursulfasec,d,e

Elaprase

Indicated for patients with Hunter syndrome (mucopolysaccharidosis II, MPS II)

10/6/06

Vorinostat

Zolinza

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

5/30/07

Temsirolimusc

Torisel

Treatment of advanced renal cell carcinoma

5/31/07

Somatropinc,e

Norditropin

Treatment of short stature in patients with Noonan’s syndrome

6/15/07

Ambrisentan

Letairis

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

8/30/07

Lanreotidec

Somatuline depot

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

9/13/07

Raloxifene

Evista

Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer

10/29/07

Nilotinibd

Tasigna

For the use for chronic phase (CP) and accelerated phase (AP) Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant to or intolerant to prior therapy that included imatinib



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