First-Time Generic Approvals: Cafcit, Claritin Hives Relief Syrup, Dermatop

Yael Waknine

September 29, 2006

September 29, 2006 —The US Food and Drug Administration (FDA) has approved first-time generic formulations for caffeine citrate 10-mg/mL intravenous injection and 10-mg/mL oral solution for the short-term treatment of apnea in premature infants, loratadine 5-mg/5-mL oral solution for the symptomatic relief of seasonal allergic rhinitis and for the treatment of chronic idiopathic urticaria, and prednicarbate 0.1% cream for the treatment of dermatoses.


Generic Caffeine Citrate (Cafcit) for Short-term Apnea in Premature Infants

On September 21, the FDA approved a first-time generic formulation for caffeine citrate 10-mg/mL intravenous injection and 10-mg/mL oral solution (made by Pharmaforce, Inc; brand name Cafcit, made by Roxane Laboratories, Inc).

Caffeine citrate is indicated for the short-term treatment of apnea of prematurity in infants with gestational ages ranging between 28 and 33 weeks.


Generic Loratadine 5-mg/5-mL Oral Solution (Claritin Hives Relief Syrup) for Rhinitis and Urticaria

On June 29, the FDA approved a first-time generic over-the-counter formulation for loratadine 5-mg/5-mL oral solution (made by Silarx Pharmaceuticals, Inc; brand name Claritin Hives Relief Syrup, a prescription product discontinued by Schering-Plough HealthCare Products). According to the FDA, the brand-name syrup formulation was not withdrawn for safety or efficacy reasons.

Loratadine oral solution is indicated for the relief of nasal and nonnasal symptoms related to seasonal allergic rhinitis and for the treatment of chronic idiopathic urticaria in patients aged 2 years and older.


Generic Prednicarbate Cream (Dermatop E Emollient) for Pruritic Dermatoses

On September 19, the FDA approved a first-time generic formulation for prednicarbate 0.1% cream (made by Altana Pharma AG; brand name Dermatop E Emollient, made by Dermik Laboratories, a division of Aventis Pharmaceuticals, Inc).

Prednicarbate 0.1% cream is a medium-potency corticosteroid indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Although it may be used with caution in pediatric patients aged 1 year and older, its safety and efficacy for treatment durations exceeding 3 weeks has not been established in this population.

Use of prednicarbate 0.1% cream in infants younger than 1 year is not recommended.

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