First-Time Generic Approvals: Corzide, Cipro XR, Cortef

Yael Waknine

April 20, 2007

April 20, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for nadolol plus bendroflumethiazide 40-mg/5-mg and 80-mg/5-mg tablets in the management of hypertension, ciprofloxacin 500- and 1000-mg extended-release tablets for the treatment of urinary tract infection, and hydrocortisone 5- and 10-mg tablets for the management of approved indications.


Generic Nadolol/Bendroflumethiazide Tablets (Corzide) for Hypertension

On March 30, the FDA approved first-time generic 40-mg/5-mg and 80-mg/5-mg formulations for nadolol plus bendroflumethiazide combination tablets (Impax Laboratories, Inc; brand name Corzide, King Pharmaceuticals, Inc).

According to a company news release, the products will be marketed in the near future.

The nonselective beta-adrenergic blocker/thiazide diuretic combination drug is indicated for the management of hypertension but should not be used as initial therapy.


Generic Ciprofloxacin Extended-Release Tablets (Cipro XR) for Urinary Tract Infection and More

On March 22, the FDA approved first-time generic 500- and 1000-mg formulations for ciprofloxacin extended-release tablets (Mylan Pharmaceuticals, Inc; brand name Cipro XR, Bayer Pharmaceuticals).

Ciprofloxacin is a fluoroquinolone antibiotic; the extended-release tablets are indicated for the treatment of acute cystitis, complicated urinary tract infections, and acute uncomplicated pyelonephritis caused by susceptible strains of designated microorganisms.


Generic Hydrocortisone 5- and 10-mg Tablets (Cortef) for Allergic States and More

On March 30, the FDA approved first-time generic formulations for hydrocortisone 5- and 10-mg tablets (Stiefel Laboratories, Inc; brand name Cortef, Pfizer, Inc).

Hydrocortisone tablets are indicated for the treatment of allergic states; endocrine and rheumatic disorders; and collagen, dermatologic, respiratory, ophthalmic, hematologic, and neoplastic diseases.

Previously approved generic formulations for the 5- and 10-mg strengths have since been discontinued by their manufacturers. The 20-mg tablet of the glucocorticoid drug has remained on the US market (West-Ward Pharmaceutical Corp).


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