First-Time Generic Approvals: Dantrium, Lexapro Capsules, Protonix

Jill Taylor

August 10, 2007

August 10, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for dantrolene sodium injectable 20 mg/vial for the management of malignant hyperthermia; escitalopram oxalate capsules EQ 5-mg, 10-mg, and 20-mg base for the treatment of major depression disorder; and pantoprazole sodium delayed release tablets EQ 20-mg and 40-mg base for the treatment of erosive esophagitis associated with gastroesophageal reflux disease and pathological hypersecretory conditions.

Generic Dantrolene Sodium ( Dantrium) for Management of Malignant Hyperthermia

On June 24, the FDA approved the first generic formulation of dantrolene sodium (generic, US WorldMeds; comparable brand, Dantrium, Proctor and Gamble) injectable 20 mg/vial for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages and for preoperative or postoperative prevention or attenuation of clinical or laboratory signs of malignant hyperthermia in susceptible individuals.

Dantrolene sodium is classified as a direct-acting skeletal muscle relaxant and has been shown to produce relaxation by affecting the contractile response of the muscle at a site beyond the myoneural junction. The addition of dantrolene sodium to "triggered" malignant hyperthermic muscle cell is thought to reestablish myoplasmic calcium equilibrium and lead to a reversal or attenuation of physiologic, metabolic, and biochemical changes associated with a malignant hyperthermia crisis.

Generic Escitalopram Oxalate Capsules ( Lexapro) for Major Depressive Disorder

On July 31, the FDA approved the first generic formulation of escitalopram oxalate (generic, AlphaPharm; comparable brand, Lexapro, Forest Pharmaceuticals, Inc) capsules EQ 5-mg, 10-mg, and 20-mg base for the treatment of major depression disorder. Generic formulations of escitalopram oxalate have previously been approved for tablets in strengths of EQ 5-mg, 10-mg, and 20-mg base.

Escitalopram oxalate belongs to a class of antidepressant medications known as selective serotonin reuptake inhibitors, which increase the extracellular level of the neurotransmitter serotonin by inhibiting its reuptake in the central nervous system with only minimal effects on other neurotransmitters, such as norepinephrine and dopamine.

Generic Pantoprazole Sodium ( Protonix) for Erosive Esophagitis and Pathological Hypersecretory Conditions

On August 2, the FDA approved the first generic formulation of pantoprazole sodium (generic, Teva Pharmaceuticals; comparable brand, Protonix, Wyeth Pharmaceuticals, Inc) delayed-release tablets EQ 20-mg and 40-mg base for the short-term treatment and healing maintenance of erosive esophagitis associated with gastroesophageal reflux disease (GERD) and for pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Pantoprazole sodium is classified as a proton pump inhibitor, a class of drugs commonly used to suppress gastric acid secretion. The medication is proven effective for conditions such as the esophageal damage caused by acid reflux, which occurs in GERD, or for peptic ulcers that occur as a result of the overproduction of gastric acid in Zollinger-Ellison syndrome.

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