TABLE C-A3 Drugs with a Pediatric Orphan Indication (1983-2008 Approvals) (27 drugs)

Exclusivity Start Date

Generic Name

Trade Name

Indication for Original Approval

10/17/85

Somatropin

Nutropin

For use in the long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion

10/17/85

Somatrem for injection

Protropin

For long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion

3/8/87

Somatropin for injection

Humatrope

For the long-term treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone

8/2/90

Colfosceril palmitate, cetyl alcohol, tyloxapol

Exosurf neonatal for intratracheal suspension

Treatment of established hyaline membrane disease at all gestational ages

1/30/91

Succimer

Chemet capsules

Treatment of lead poisoning in children

7/1/91

Beractant

Survanta intratracheal suspension

(1) Prevention of RDS (hyaline membrane disease) in premature infants less than 1250 grams birth weight or with evidence of surfactant deficiency. (2) Treatment of (“rescue”) premature infants with RDS confirmed by x-ray and requiring mechanical ventilation.

12/24/91

Histrelin acetate

Supprelin injection

Treatment of central precocious puberty

2/26/92

Nafarelin acetate

Synarel nasal solution

Treatment of central precocious puberty

7/14/92

Teniposide

Vumon for injection

Induction therapy in patients with refractory childhood acute lymphoblastic leukemia

4/16/93

Leuprolide acetate

Lupron injection

Treatment of children with central precocious puberty

7/29/93

Felbamate

Felbatol

As adjunctive therapy in the treatment of partial and generalized seizures associated with the Lennox-Gastaut syndrome in children

12/27/93

Immune globulin intravenous, human

Gamimune N

Infection prophylaxis in pediatric patients affected with the human immunodeficiency virus



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