First-Time Generic Approvals: Paxil CR, Lamisil, Parlodel

Jill Taylor

July 12, 2007

July 13, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for paroxetine hydrochloride extended release tablets, 12.5 mg and 25 mg, for the treatment of certain psychiatric disorders, terbinafine hydrochloride 250-mg tablets for prescription treatment and terbinafine hydrochloride cream 1% for over-the-counter treatment of fungal infections, and bromocriptine mesylate capsules 5 mg for the treatment of hyperprolactinemia-associated dysfunctions, acromegaly, and Parkinson's disease.

Generic Paroxetine Hydrochloride (Paxil CR) for Treatment of Major Depressive Disorder, Panic Disorder, and Premenstrual Dysphoric Disorder

On June 29, the FDA approved the first 12.5-mg and 25-mg generic formulations of paroxetine hydrochloride extended release tablets (generic, Mylan; comparable brand, Paxil CR, GlaxoSmithKline) for the treatment of major depressive disorder, panic disorder, and premenstrual dysphoric disorder.

Paroxetine hydrochloride is a psychotropic drug for which efficacy is believed to be linked to the inhibition of the neuronal reuptake of serotonin. However, it is structurally unrelated to other selective serotonin reuptake inhibitors, as well as tricyclic, tetracyclic, or other available antidepressant or antipanic agents.

Generic Terbinafine Hydrochloride (Lamisil) 250-mg Tablets and 1% Cream for Fungal Infections

On July 2, the FDA approved the first 250-mg generic formulation of terbinafine hydrochloride tablets (comparable brand, Lamisil, Novartis) for prescription treatment of fungal infections in the nails and terbinafine hydrochloride 1% cream for over-the-counter treatment of athlete's foot.

Approval was given to applications from multiple generic drug manufacturers for the prescription tablet formulation, including Amneal Pharmaceuticals, Apotex Corp, Aurobindo Pharma USA Inc, Dr. Reddy's Laboratories Ltd, Gedeon Richter USA Inc, Genpharm Inc, Glenmark Pharmaceuticals Inc, InvaGen Pharmaceuticals Inc, Mylan Pharmaceuticals Inc, Orgenus Pharma Inc, Roxane Laboratories Inc, TEVA Pharmaceuticals USA, Watson Laboratories Inc, and Wockhardt USA Inc. The application for the over-the-counter cream formulation was approved for Taro Pharmaceuticals USA Inc.

Generic Bromocriptine Mesylate (Parlodel) for Hyperprolactinemia-Associated Dysfunctions, Acromegaly, and Parkinson's Disease

On July 9, the FDA approved the first 5-mg generic formulation of bromocriptine mesylate capsules (generic, Mylan; comparable brand, Parlodel, Novartis) for the treatment of hyperprolactinemia-associated dysfunctions, acromegaly, and Parkinson's disease.

Bromocriptine mesylate is a nonhormonal, nonestrogenic agent that inhibits the secretion of prolactin, a gonadotropic hormone secreted by the pituitary gland. Although it has little or no effect on other pituitary hormones, bromocriptine mesylate has been shown to lower circulating levels of serum growth hormone in the majority of patients with acromegaly. The therapeutic effect of bromocriptine mesylate in Parkinson's disease is produced by direct stimulation of dopamine receptors in the corpus striatum.

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