Generic Product News

Published Online: Wednesday, August 10, 2011
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Donepezil

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

For More Information: www.tevausa.com; 888-838-2872


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

For More Information: www.drreddys.com


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

For More Information: www.amneal.com


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

For More Information: www.sagentpharma.com; www.stridesarco.com



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Today Reps. Doug Collins (R-Ga.) and Dave Loebsack (D-Iowa) introduced H.R. 5815, The Generic Drug Pricing Fairness Act, which creates greater transparency in how pharmacy benefit managers reimburse pharmacies for generic prescription drugs under Medicare Part D, and the Federal Employees Health Benefits Program. The National Community Pharmacists Association endorsed the bill, which goes further than legislation the same two Congressmen introduced earlier year that has the same remedies, but only applied to Medicare Part D.
“GPhA applauds FDA for taking helpful steps to address, and hopefully limit, scenarios in which some brand drug companies misuse Risk Evaluation and Mitigation Strategies programs to thwart competition from more affordable generic drugs. The ongoing abuse of REMS and REMS-like programs costs the American health system and its patients $5.4 billion annually, according to a study conducted by Matrix Global Advisors. Interestingly, as the United States market readies for biosimilars, this same study identifies $140 million in lost savings that would occur for every $1 billion in biologics sales.
Generics saved $239 billion in 2013 (a 14% increase in savings from 2012) and more than $1.46 trillion over the recent decade. Further, the Express Scripts 2013 Drug Trend Report issued in 2014 shows that since 2008, the price of brand drugs has almost doubled, but the price of generic drugs has been cut roughly in half.
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