First-Time Generic Approvals: Focalin, Valtrex, Hydrodiuril

Yael Waknine

February 16, 2007

February 16, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for dexmethylphenidate HCl tablets in the treatment of attention-deficit/hyperactivity disorder, valacyclovir HCl tablets for the treatment of genital herpes and shingles, and hydrochlorothiazide 12.5-mg tablets for the treatment of edema and hypertension.


Generic Dexmethylphenidate HCl Tablets (Focalin) for ADHD

On January 29, the FDA approved first-time generic 2.5-, 5-, and 10-mg formulations for dexmethylphenidate HCl tablets (made by Teva Pharmaceuticals USA; brand name Focalin, made by Novartis Pharmaceuticals Corp).

Dexmethylphenidate tablets are indicated for the treatment of attention-deficit/hyperactivity disorder in patients aged 6 to 17 years.


Generic Valacyclovir HCl Tablets (Valtrex) for Genital Herpes, Shingles

On January 31, the FDA approved first-time generic formulations for valacyclovir HCl 500-mg and 1-g tablets (made by Ranbaxy, Inc; brand name Valtrex, made by GlaxoSmithKline).

Valacyclovir is indicated for the treatment/suppression of genital herpes in immunocompetent individuals and for the suppression of recurrent genital herpes in HIV-infected patients. It also may be used for the treatment of herpes zoster (shingles).


Generic Hydrochlorothiazide 12.5-mg Tablets (Hydrodiuril) for Edema, Hypertension

On January 23, the FDA approved a first-time generic 12.5-mg formulation for hydrochlorothiazide (HCTZ) tablets (made by Mylan Pharmaceuticals, Inc; brand name Hydrodiuril, discontinued by Merck and Co, Inc).

The FDA notes that although generic formulations of HCTZ 12.5-mg capsules were previously approved, the current approval represents the first for generic tablets in this strength.

HCTZ is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy; and for use alone or with other agents for the management of hypertension. It has also been found useful for edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.

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