First-Time Generic Approvals: Toprol-XL, Suprax, Lotrel

Jill Taylor

May 25, 2007

May 25, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for metoprolol succinate 100-mg and 200-mg extended-release tablets for the treatment of hypertension; cefixime oral suspension 200 mg/5 mL for the treatment of bacterial infections; and amlodipine besylate/benazepril products in 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg dose strengths for the treatment of hypertension.


Generic Metoprolol Succinate Extended-Release Tablets ( Toprol-XL) for Hypertension and More

On May 18, the FDA approved 100-mg and 200-mg strengths of metoprolol succinate extended-release tablets (KV Pharmaceutical Company; brand name Toprol-XL, AstraZeneca).

Metoprolol succinate is a cardioselective adrenergic receptor blocking agent, indicated for the treatment of hypertension, long-term treatment of angina pectoris, and for stable, symptomatic (NYHA class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.

According to a news release, KV Pharmaceutical Company anticipates being granted a 180-day generic exclusivity period for the marketing of these 2 dose strengths based on the first-to-file status on its ANDA. The company is also waiting for FDA approval of an ANDA for 2 additional dose strengths, 25 mg and 50 mg.


Generic Cefixime for Oral Suspension ( Suprax) for Bacterial Infection

On April 10, the FDA approved the first generic formulation of cefixime for oral suspension 200 mg/5 mL (Lupin Pharmaceuticals, Inc; brand name Suprax, Lederle Laboratories). Belonging to the cephalosporin class of antibiotics, cefixime oral suspension is used to treat certain bacterial infections of the throat, middle ear, airways, urinary tract, and genital systems in children.

This newly approved formulation is a higher concentration than the formulation available to date (cefixime for oral suspension 100 mg/5 mL), thus reducing by half the number of teaspoons administered per dose.


Generic Amlodipine Besylate/Benazepril ( Lotrel) for Hypertension

On May 18, the FDA approved the first generic formulation of amlodipine besylate/benazepril products in 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, and 10 mg/20 mg dose strengths (Teva Pharmaceutical Industries Ltd; brand name Lotrel, Novartis).

Offered in capsule form, the product is a combination of a besylate salt of amolodipine, a peripheral arterial vasodilator, and benazepril hydrochloride, which is converted to an angiotensin-converting enzyme (ACE) inhibitor during metabolism. It is indicated for the treatment of hypertension.

Teva had been awarded 180 days of marketing exclusivity for this product due to being the first company to file an abbreviated new drug application with a paragraph IV patent certification. However, on May 19, the United States District Court for the District of New Jersey granted an emergency request made by Novartis for a temporary order restraining drug shipments on the grounds of patent infringement.


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