First-Time Generic Approvals: Maxipime, Tessalon 200 mg, Vesanoid

Jill Taylor

June 29, 2007

June 29, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for cefepime hydrochloride 500 mg, 1 g, and 2 g base/vial for parenteral administration in the treatment of bacterial infections; benzonatate 200 mg for the treatment of cough; and tretinoin 10 mg capsules for the induction of remission in patients with acute promyelocytic leukemia (APL) and more.

Generic Cefepime Hydrochloride ( Maxipime) for Injection for Bacterial Infection

On June 18, the FDA approved the first generic formulation of cefepime hydrochloride (generic, Orchid Healthcare; comparable brand, Maxipime, Bristol-Myers Squibb Company) 500-mg, 1-g, and 2-g base/vial for parenteral administration in the treatment of bacterial infections.

Cefepime hydrochloride is a semisynthetic, broad-spectrum cephalosporin antibiotic that can be administered by either intramuscular or intravenous injection. Its broad spectrum of activity encompasses a wide range of bacteria, including gram-negative microorganisms, such as Enterobacter, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa, and gram-positive microorganisms, such as methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, and Viridans group streptococci.

Generic Benzonatate 200 mg ( Tessalon) for Cough

On April 10, the FDA approved the first generic formulation of benzonatate 200-mg capsules (generic, Zydus Pharmaceuticals, Inc; comparable brand, Tessalon, Forest Laboratories, Inc) for the symptomatic relief of cough. A generic 100-mg version of the drug has been previously approved.

Although it is nonnarcotic, benzonatate depresses the central nervous system, an effect similar to that of codeine. Benzonatate also acts as a local anesthetic, which affects the stretch receptors in the lower respiratory tract that control coughing and will numb the mouth, tongue, and pharynx if the capsules are chewed.

Generic Tretinoin ( Vesanoid) for Induction of Remission in Acute Promyelocytic Leukemia

On June 21, the FDA approved the first generic formulation of tretinoin 10-mg capsules (generic, Barr Laboratories, Inc; comparable brand, Vesanoid, Roche Laboratories, Inc) for the induction of remission in patients with acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3 (including the M3 variant), characterized by the presence of the t(15;17) translocation or the presence of the PML/RARa gene, who are refractory to or who have relapsed from anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contradicted.

APL is characterized by abnormal, heavily granulated promyelocytes, a form of white blood cell, which replace normal blood cells in the bone marrow and peripheral blood. Tretinoin works by inducing the maturation of primitive promyelocytes, after which normal polyclonal hematopoietic cells can repopulate.

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