First-Time Generic Approvals: Aciphex, Zantac Syrup, Uniretic

Yael Waknine

March 13, 2007

March 13, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for rabeprazole sodium 20-mg delayed-release tablets and ranitidine HCl 15-mg/mL oral solution/syrup for the treatment of certain upper gastrointestinal disorders. The FDA also approved moexipril HCl plus hydrochlorothiazide 12.5-mg/7.5-mg, 25-mg/15-mg, and 12.5-mg/15-mg tablets for the treatment of hypertension.

Generic Rabeprazole Sodium 20-mg Delayed-Release Tablets ( Aciphex ) for Upper GI Use

On February 21, the FDA approved a first-time generic 20-mg formulation for rabeprazole sodium delayed-release tablets (Teva Pharmaceutical Industries, Ltd; brand name Aciphex , Eisai Medical Research, Inc).

Rabeprazole delayed-release tablets are indicated for the healing of erosive or ulcerative gastroesophageal reflux disease (GERD); maintenance of erosive/ulcerative GERD healing; treatment of symptomatic GERD; healing of duodenal ulcers; and treatment of hypersecretory conditions, including Zollinger-Ellison syndrome.

Rabeprazole may also be used in combination with amoxicillin and clarithromycin for the eradication of Helicobacter pylori infection to reduce the risk for duodenal ulcer recurrence.

Generic Ranitidine 15-mg/mL Syrup ( Zantac ) for GERD and Other GI Disorders

On February 21, the FDA approved a first-time generic 15-mg/mL formulation for ranitidine HCl oral solution/syrup (Alpharma, Inc [Actavis Group]; brand name Zantac , GlaxoSmithKline).

According to a company news release, product distribution will begin this month.

Ranitidine syrup is indicated in the short-term treatment of active duodenal ulcers and active, benign gastric ulcers; maintenance therapy for duodenal and gastric ulcers; and the treatment of pathologic hypersecretory conditions (eg, Zollinger-Ellison syndrome and systemic mastocytosis).

It also may be used for the treatment of gastroesophageal reflux disease and for the treatment of erosive esophagitis.

Generic Moexipril HCl/HCTZ Tablets ( Uniretic ) for Hypertension

On March 9, the FDA approved first-time generic 12.5-mg/7.5-mg, 25-mg/15-mg, and 12.5-mg/15-mg formulations for moexipril HCl plus hydrochlorothiazide [HCTZ] tablets (Teva Pharmaceutical Industries, Ltd; brand name Uniretic , Schwarz Pharma, Inc).

According to a company news release, shipments of the product will begin immediately. Moexipril/HCTZ tablets are indicated for the treatment of hypertension; they are not intended for first-line use.


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