First-Time Generic Approvals: Penlac, Tussionex Pennkinetic, Cerebyx

Jill Taylor

October 26, 2007

October 26, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for ciclopirox topical solution (nail lacquer) 8% for treatment of mild to moderate onychomycosis of fingernails and toenails, hydrocodone polistirex and chlorpheniramine polistirex suspension in 5-mg/4-mg and 10-mg/8-mg strengths for relief of cough and upper respiratory symptoms associated with allergy or a cold, and fosphenytoin sodium injection EQ 50 mg/mL strength for short-term parenteral administration when other means of phenytoin administration are unavailable, inappropriate, or deemed less advantageous.

Generic Ciclopirox Topical Solution ( Penlac) for Mild to Moderate Onychomycosis of Fingernails and Toenails

On September 18, the FDA approved the first generic formulation of ciclopirox topical solution (comparable brand, Penlac nail lacquer, Sanofi Aventis) 8% for treatment in immunocompetent patients of mild to moderate onychomycosis of fingernails and toenails without lunula involvement resulting from Trichophyton rubrum.

Generic formulations of ciclopirox topical solution were approved for the following generic drug companies: Actavis Mid Atlantic, Apotex Corporation, G and W Laboratories, Hi Tech Pharmacal Co, Perrigo New York, Synerx Pharma, Taro Pharmaceutical Industries, Teva Pharmaceutical Industries, Tolmar, and Watson Pharmaceuticals.

Onychomycosis, a fungal infection of the bed, matrix, or plate of the nail, accounts for half of all nail disease. The most common form of infection is subungual onychomycosis, which is usually caused by T rubrum.

Ciclopirox is a synthetic antifungal agent for which the mechanism of action has not been firmly established. It is used as a component of a comprehensive management program that includes removal of the unattached, infected nails.

Generic Hydrocodone Polistirex and Chlorpheniramine Polistirex Suspension ( Tussionex Pennkinetic) for Relief of Cough and Upper Respiratory Symptoms

On September 24, the FDA approved the first generic formulations of hydrocodone polistirex and chlorpheniramine polistirex suspension (generic, Tyco Healthcare/Mallinckrodt; comparable brand, Tussionex Pennkinetic, UCB, Inc) in 5-mg/4-mg and 10-mg/8-mg strengths for relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age and older.

Hydrocodone, a semisynthetic narcotic with actions qualitatively similar to codeine, is believed to work directly on the cough center. Chlorpheniramine, an H1 receptor antagonist, acts as an antihistamine. Both agents are presented as a part of sulfonated tyrene-divinylbenzene copolymer (polistirex) complexes for extended-release purposes.

Generic Fosphenytoin Sodium Injection ( Cerebyx) for Convulsions and Seizures

On August 6, the FDA approved the first generic formulation of fosphenytoin sodium injection (comparable brand, Cerebyx, Parke-Davis) EQ 50 mg/mL strength for short-term parenteral administration when other means of phenytoin administration are unavailable, inappropriate, or deemed less advantageous.

Fosphenytoin sodium injection is a prodrug of phenytoin, an antiepileptic agent that appears to act on the motor cortex to inhibit the spread of seizure activity. It can be used for control of generalized convulsive status epilepticus and prevention and treatment of seizures during neurosurgery, and it may be used as a short-term substitution for oral phenytoin.

Generic formulations of fosphenytoin sodium injection were approved for the following generic drug companies: Abraxis Pharmaceutical Products, Apotex Corporation, Baxter Healthcare, Bedford Laboratories, Hospira, IV Therapeutics, TevaParenteral, and Wockhardt.

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