First-Time Generic Approvals: Verelan PM, Cefotan, Nasarel

Jill Taylor

August 17, 2007

August 17, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for verapamil hydrochloride 100-, 200-, and 300-mg extended-release capsules for the management of essential hypertension; cefotetan disodium injectable EQ 1 gm base/vial and EQ 2 gm base/vial for the therapeutic treatment of infections caused by susceptible strains of bacteria; and flunisolide metered spray 0.029 mg/spray for the management of the nasal symptoms of seasonal or perennial rhinitis.

 

Generic Verapamil Hydrochloride ( Verelan PM) for Management of Essential Hypertension

On August 9, the FDA approved the first generic formulation of verapamil hydrochloride (generic, Mylan; comparable brand, Verelan PM, Elan Drug Delivery, Inc) 100-, 200-, and 300 mg extended-release capsules for the management of essential hypertension.

According to the National Heart, Lung, and Blood Institute, an estimated 50 million people in the United States alone have hypertension that warrants treatment. Worldwide, hypertension is estimated to affect up to 1 billion people and is implicated in approximately 7.1 million deaths annually.

Verapamil hydrochloride is a calcium channel agonist that produces an antihypertensive effect through a combination of vascular and cardiac effects. It acts as a vasodilator with selectivity for the arterial portion of the peripheral vasculature, reducing systemic vascular resistance.

Generic Cefotetan Disodium Injectable ( Cefotan) for Bacterial Infections

On August 9, the FDA approved the first generic formulation of cefotetan disodium (generic, Abraxis Pharmaceutical Products; comparable brand, Cefotan, AstraZeneca) injectable EQ 1 gm base/vial and EQ 2 gm base/vial for the therapeutic treatment of infections caused by susceptible strains of bacteria.

Cefotetan disodium is a second-generation cephalosporin that is indicated for the therapeutic treatment of infections caused by susceptible bacterial strains and as a prophylaxis against some postoperative infections in patients undergoing surgical procedures that are classified as clean contaminated or potentially contaminated.

According to a press release by Abraxis Pharmaceutical Products, cefotetan has the longest half-life of any first- or second-generation cephalosporin. Because AstraZeneca's Cefotan was withdrawn from the marketplace as a result of issues with sourcing of raw material in 2006, Abraxis Pharmaceutical Products is currently the only supplier of the drug.

Generic Flunisolide ( Nasarel) for Nasal Symptoms of Allergic Rhinitis

On August 9, the FDA approved the first generic formulation of flunisolide metered spray (generic, Apotex, Inc; comparable brand, Nasarel, IVAX Laboratories, Inc) 0.029 mg/spray for the management of the nasal symptoms of seasonal or perennial rhinitis.

According to the American College of Allergy, Asthma, and Immunology, more than 50 million Americans currently suffer from allergic rhinitis. Research suggests that the condition, which affects both adults and children, is strongly associated with comorbidities such as asthma, migraine headaches, and depression.

Flunisolide is an anti-inflammatory glucocorticosteroid demonstrated to be effective in treating the symptoms of allergic rhinitis, including rhinorrhea, nasal congestion, and sneezing.

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