First-Time Generic Approvals: Zoloft, Urocit-K, Parnate

Yael Waknine

July 11, 2006

July 11, 2006 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for sertraline HCl 25-, 50-, and 100-mg tablets in the treatment of adults with major depression and other mental health disorders; potassium citrate 5- and 10-mEq extended-release tablets for the prevention of kidney stone formation; and tranylcypromine sulfate 10-mg tablets for the treatment of major depressive disorder without melancholia in adults.


Generic Sertraline HCl 25-, 50-, and 100-mg Tablets (Zoloft) for Mental Health Disorders

On June 30, the FDA approved first-time generic formulations for sertraline HCl 25-, 50-, and 100-mg tablets (made by Ivax Pharmaceuticals, Inc [now owned by Teva Pharmaceuticals Industries]; brand name Zoloft, made by Pfizer, Inc).

A generic formulation for the 20-mg/mL oral concentrate (made by Roxane Laboratories, Inc, a unit of Boehringer Ingelheim) was also approved.

According to a statement in a company news release, Pfizer will also market its own generic formulation through its Greenstone, Ltd, unit.

Sertraline tablets and oral solution are indicated for the treatment of major depressive disorder, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, premenstrual dysphoric disorder, and social anxiety disorder in adults.


Generic Potassium Citrate 5- and 10-mEq Extended-Release Tablets (Urocit-K) for Kidney Stones

On June 8, the FDA approved first-time generic formulations for potassium citrate 5- and 10-mEq extended-release tablets (made by CorePharma, LLC; brand name Urocit-K, made by Mission Pharmacal).

Potassium citrate tablets are indicated for the management of renal tubular acidosis with calcium stones; hypocitraturic calcium oxalate nephrolithiasis of any etiology; and uric acid lithiasis with or without calcium stones.


Generic Tranylcypromine 10-mg Tablets (Parnate) for Depression Without Melancholia

On June 29, the FDA announced approved a first-time generic formulation for tranylcypromine sulfate 10-mg tablets (made by Kali Laboratories, Inc; brand name Parnate, made by GlaxoSmithKline).

Tranylcypromine tablets are indicated for the treatment of major depressive episodes without melancholia in adults. They should be reserved for use in patients who have failed to respond to more commonly prescribed antidepressant drugs.

Reviewed by Gary D. Vogin, MD

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