Exclusivity Start Date

Generic Name

Trade Name

Indication for Original Approval

1/18/96

Respiratory syncytial virus immune globulin (human)

Respigam

Prophylaxis of respiratory syncytial virus (RSV) lower respiratory tract infections in infants and young children at high risk of RSV disease

9/26/97

Sermorelin acetate

Geref

Treatment of idiopathic or organic growth hormone deficiency in children with growth failure

5/27/99

Etanercept

Enbrel

Reduction in signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying antirheumatic drugs

9/21/99

Caffeine

Cafcit

Short-term treatment of apnea of prematurity in infants between 28 and less than 33 weeks gestational age

6/20/00

Somatropin (r-DNA)

Genotropin

Long-term treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS)

7/12/02

Rasburicase

Elitek

Treatment of malignancy-associated or chemotherapy-induced hyperuricemia

7/29/03

Ribavirin

Rebetol

Treatment of chronic hepatitis C among previously untreated pediatric patients at least 3 years of age or older

10/23/03

Botulism immune globulin

Babybig

Indicated for treatment of infant botulism caused by type A or type B Clostridium botulinum

12/28/04

Clofarabine

Clolar

Treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens

8/11/05

Meloxicam

Mobic

For relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients 2 years of age or older

8/30/05

Mecasermin

Increlex

Long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH

12/12/05

Mecasermin rinfabate

Iplex

Treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH



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