Generic Product News

AUGUST 10, 2011


Donepezil HCl Tablets

Marketed by: Teva Pharmaceuticals (North Wales, PA)

Compared to: Aricept (Eisai)

Indication: Teva launched donepezil HCl tablets, an AB-rated bioequivalent generic version of Aricept tablets. Donepezil is a cholinesterase inhibitor indicated for the treatment of dementia in patients with mild, moderate, and severe Alzheimer’s disease. The recommended dosage is 5 or 10 mg for mild to moderate Alzheimer’s disease and 10 mg for severe Alzheimer’s disease, administered once daily at bedtime. Patients taking donepezil should be counseled to inform their pharmacist and physician if they are receiving concurrent nonsteroidal anti-inflammatory drugs, which may increase risk of gastrointestinal bleeding.

Dosage Form: Tablets: 5 and 10 mg

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Venlafaxine HCL Extended Release Capsules

Marketed by: Dr. Reddy’s Laboratories (Hyderabad, India)

Compared to: Effexor XR (Pfizer)

Indication: Dr. Reddy’s announced the FDA approval and subsequent launch of venlafaxine HCl extended release capsules, a bioequivalent generic version of Pfizer’s Effexor XR. Venlafaxine is indicated for the treatment of depression, a common disease that affects more than 1 in 20 Americans 12 years and older, according to the Centers for Disease Control and Prevention. The recommended starting dose for venlafaxine extended release tablets is 75 mg per day, administered once daily with food. New patients may be prescribed a starting dose of 37.5 mg per day for an adjustment period of 4 to 7 days before increasing to 75 mg per day.

Dosage Form: Extended release capsules: 37.5, 75, and 150 mg

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RisperidoneRisperidone Oral Solution

Marketed by: Amneal Pharmaceuticals (Bridgewater, NJ)

Compared to: Risperdal (Ortho- McNeil-Janssen, a division of Johnson & Johnson)

Indication: FDA approved Amneal’s risperidone oral solution, an AA-rated, therapeutically equivalent alternative to Risperdal. Amneal’s product is indicated for the treatment of schizophrenia in adults and adolescents aged 13 to 17 years, bipolar disorder in adults and children and adolescents aged 10 to 17 years, and irritability associated with autism in children and adolescents aged 5 to 16 years. It is supplied in 30-mL bottles with a calibrated pipette and can be administered directly or mixed with 3 to 4 oz of a beverage prior to administration. Patients and caregivers should be reminded that risperidone oral solution is compatible in water, coffee, orange juice, and low-fat milk, but not cola or tea.

Dosage Form: Oral solution: 1 mg/mL strength

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Polymyxin B for Injection, USP PolymyxinB

Marketed by: Sagent Pharmaceuticals (Schaumburg, IL)

Supplied by: Strides Arcolab (Bangalore, India)

Indication: Sagent Pharmaceuticals, in partnership with Strides Arcolab, announced the FDA approval of polymyxin B for injection, USP. Polymyxin B is an antibacterial drug indicated for the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Pseudomonas aeruginosa. It may also be used topically and subconjunctivally in the treatment of ophthalmic infections caused by susceptible strains of Pseudomonas aeruginosa. The product is expected to launch in the third quarter of 2011 and will be supplied by Strides Arcolab and marketed in the United States by Sagent.

Dosage Form: Latex-free glass vials: 500,000 units polymyxin B per vial

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