First-Time Generic Approvals: Celexa Capsules, Videx Pediatric Powder, Dermatop Ointment

Yael Waknine

March 16, 2007

March 16, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for citalopram HBr capsules in the treatment of depression, didanosine pediatric powder for 10-mg/mL oral solution for the treatment of HIV-1 infection, and prednicarbate 0.1% ointment for the topical treatment of corticosteroid-responsive dermatoses.

New Generic Citalopram Capsule Formulation ( Celexa ) for Depression

On February 28, the FDA approved first-time generic and new formulations for citalopram HBr 10-, 20-, and 40-mg capsules (Alphapharm Pty, Ltd; brand name Celexa tablets, Forest Laboratories, Inc).

Generic versions of citalopram tablets and oral solution previously were approved by FDA. The drug, a selective serotonin reuptake inhibitor, is indicated for the treatment of depression.

Generic Didanosine Oral Solution ( Videx Pediatric Powder ) for Anti-HIV Therapeutic Regimens

On March 8, the FDA approved a first-time generic formulation for didanosine pediatric powder for 10 mg/mL oral solution, packaged in 2- and 4-g containers (Aurobindo Pharma Ltd; brand name Videx Pediatric Powder , Bristol-Myers Squibb Co).

According to an FDA news release, tentative approval for the product was previously granted on October 5, 2006, allowing its purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).

Didanosine, a nucleoside analog, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Generic Prednicarbate 0.1% Ointment ( Dermatop ) for Dermatoses

On March 9, the FDA approved a first-time generic formulation for prednicarbate 0.1% ointment (Altana; brand name Dermatop , Dermik Laboratories, a division of Aventis Pharmaceuticals, Inc).

The ointment, a medium-potency topical corticosteroid, is indicated for the relief of inflammatory and pruritic manifestations of treatment-responsive dermatoses.


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