Product News
Divalproex Sodium Delayed-Release Tablets
Marketed by:
Sun Pharmaceutical Industries Ltd
Compared to:
Depakote (Abbott Laboratories)
Indication:
August 11, 2008?Sun Pharmaceutical Industries Ltd announced that the FDA granted approval for its Abbreviated New Drug Application for divalproex sodium delayed-release tablets, a generic version of Depakote. Divalproex sodium delayedrelease tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures, as sole and adjunct therapy for patients with simple and complex absence seizures, for the treatment of the manic episodes associated with bipolar disorders, as well as for the prophylaxis of migraine headaches.
Dosage Form:
Tablets: 125, 250, and 500 mg
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Dronabinol
Marketed by:
Watson Pharmaceuticals Inc (Corona, CA)
Compared to:
Marinol CIII Capsules (Solvay Pharmaceuticals Inc)
Indication:
June 30, 2008?Watson Pharmaceuticals Inc announced that, under a supply agreement with Solvay Pharmaceuticals Inc, Watson launched the authorized generic version of dronabinol in the 2.5-, 5-, and 10-mg once-daily dosage strengths. Dronabinol is indicated to treat nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. The product also is indicated to treat anorexia associated with weight loss in patients with AIDS. Dronabinol should not be used by any patient who has a history of hypersensitivity to any cannabinoid or to sesame oil.
Dosage Form:
Capsules: 2.5, 5, and 10 mg
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Galantamine Hydrobromide
Marketed by:
Barr Pharmaceuticals Inc (Montvale, NJ)
Compared to:
Razadyne (Ortho-McNeil-Janssen)
Indication:
August 28, 2008?Barr Pharmaceuticals Inc announced that its subsidiary, Barr Laboratories Inc, received final approval from the FDA to manufacture and market galantamine hydrobromide tablets, a generic version of Razadyne, for the treatment of mild-to-moderate dementia of the Alzheimer?s type. The recommended starting dose of the tablets is 4 mg twice a day (8 mg/day). The dose should be increased to the initial maintenance dose of 8 mg twice a day (16 mg/day) after a minimum of 4 weeks. A further increase to 12 mg twice a day (24 mg/day) should be attempted after a minimum of 4 weeks at 8 mg twice a day.
Dosage Form:
Tablets: 4, 8, and 12 mg
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Risperidone
Marketed by:
Teva Pharmaceuticals (North Wales, PA)
Compared to:
Risperdal (Johnson & Johnson)
Indication:
June 30, 2008?Teva Pharmaceuticals announced the introduction and availability of risperidone, 0.25, 0.5, 1, 2, 3, and 4 mg. This product is AB-rated to Risperdal tablets. Risperidone is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults, as well as alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder. Teva has 180 days of market exclusivity for the product.
Dosage Form:
Tablets: 0.25, 0.5, 1, 2, 3, and 4 mg
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