Generic Product News

Pharmacy TimesJuly 2009
Volume 75
Issue 7

Alprazolam Extended-Release Tablets

Marketed by: Amneal Pharmaceuticals (Hauppauge, NY)

Compared to: Xanax XR (Pfizer Inc)

Indication: Amneal Pharmaceuticals announced the availability of its Alprazolam Extended-Release (ER) Tablets in strengths of 0.5, 1, 2, and 3 mg. This product is indicated for the treatment of panic disorder with or without agoraphobia and is an antianxiety Schedule IV controlled substance. Alprazolam ER is AB-rated and therapeutically equivalent to Xanax XR. Amneal was able to obtain FDA approval to manufacture Alprazolam ER as a result of acquiring Interpharm’s product line last year.

Dosage Form: Tablets: 0.5, 1, 2, and 3 mg

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Marketed by: Sandoz (Princeton, NJ)

Compared to: Vantin (Pfizer Inc)

Indication: Sandoz announced the introduction of Cefpodoxime Proxetil Tablets in the United States. Cefpodoxime Proxetil is a cephalosporin antibiotic indicated to treat mild-tomoderate infections caused by gram-positive and gramnegative bacteria, such as ear infections, sore throats, and sinusitis. The tablets are available in 100- and 200-mg strengths. Dosage Form: Tablets: 100 and 200 mg

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Ursodiol Tablets USP, 250 and 500 mg

Marketed by: Teva Pharmaceuticals (North Wales, PA)

Compared to: Urso 250 Tablets and Urso Forte Tablets (Axcan Pharma Inc)

Indication: Teva Pharmaceuticals announced the introduction and availability of Ursodiol Tablets USP, 250 mg and 500 mg. This product is AB-rated and bioequivalent to Urso 250 Tablets and Urso Forte Tablets, respectively. These tablets are indicated for the treatment of patients with primary biliary cirrhosis (PBC). The recommended adult dosage for Ursodiol tablets in the treatment of PBC is 13 to 15 mg/ kg/day administered in 2 to 4 divided doses with food.

Dosage Form: Tablets: 250 and 500 mg

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Mycophenolate Mofetil

Marketed by: Roxane Laboratories (Columbus, OH)

Compared to: CellCept (Hoffmann-La Roche Inc)

Indication: Roxane Laboratories announced the launch of Mycophenolate Mofetil 250-mg capsules and 500- mg tablets. Mycophenolate Mofetil is AB-rated to CellCept, and is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants. The product should be used concomitantly with cyclosporine and corticosteroids. Mycophenolate Mofetil has been administered in combination with the following agents in clinical trials: antithymocyte globulin (Atgam), OKT3 (Orthoclone OKT4 3), cyclosporine (Sandimmune, Neoral), and corticosteroids. The efficacy and safety of the use of Mycophenolate Mofetil in combination with other immunosuppressive agents have not been determined.

Dosage Form: Capsules: 250 mg Tablets: 500 mg

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