First-Time Generic Approvals: Rifamate Capsules, Locoid Ointment, Klonopin ODT

Yael Waknine

August 16, 2005

Aug. 16, 2005 — The U.S. Food and Drug Administration (FDA) has approved first-time generic formulations of rifampin plus isoniazid 300-mg/150-mg capsules for the treatment of pulmonary tuberculosis; hydrocortisone butyrate 0.1% ointment for relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses; and clonazepam 0.125-, 0.25-, 0.5-, 1-, and 2-mg orally disintegrating tablets for the treatment of seizure and panic disorders.

 

Generic Rifampin/Isoniazid Capsules (Rifamate) for Pulmonary TB

 

On July 29, the FDA approved a first-time generic formulation of rifampin plus isoniazid 300-mg/150-mg capsules (made by West-Ward Pharmaceutical Corp.; brand name, Rifamate; made by Aventis Pharmaceuticals).

Rifampin plus isoniazid capsules are indicated for the treatment of pulmonary tuberculosis due to susceptible organisms in patients who have been titrated on the individual components to establish therapeutic efficacy at the fixed doses of the combination drug. The combination is not recommended for initial therapy of tuberculosis or for preventive therapy.

 

Generic Hydrocortisone Butyrate 0.1% Cream (Locoid) for Dermatoses

 

On Aug. 4, the FDA approved a first-time generic formulation of hydrocortisone butyrate 0.1% cream (made by Taro Pharmaceutical Industries USA, Inc.; brand name, Locoid; made by Ferndale Laboratories, Inc.).

The approval follows that of generic hydrocortisone butyrate 0.1% ointment on Dec. 27, 2004.

Hydrocortisone butyrate 0.1% ointment and cream are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Generic Clonazepam ODT (Klonopin) for Seizure and Panic Disorders

 

On Aug. 3, the FDA approved first-time generic formulations of clonazepam 0.125-, 0.25-, 0.5-, 1-, and 2-mg orally disintegrating tablets ([ODT] made by Kali Laboratories, Inc.; brand name, Klonopin rapidly disintegrating tablets; made by Roche).

Generic formulations of clonazepam ODT made by Barr Pharmaceuticals, Inc., were approved on Aug. 10.

Clonazepam ODT is indicated for use alone or as an adjunct in the treatment of seizure disorders including akinetic and myoclonic seizures, and Lennox-Gastaut syndrome (petit mal variant). It is also indicated as monotherapy for panic disorder with or without agoraphobia, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.

Reviewed by Gary D. Vogin, MD

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