Generic Products

NOVEMBER 16, 2011

Felbamate Tablets

Marketed by: Amneal Pharmaceuticals (Bridgewater, NJ)

Compared to: Felbatol (Meda Pharmaceuticals)

Indication: The FDA approved Amneal’s felbamate tablets, the first generic alternative to the antiepileptic drug (AED) Felbatol. Due to the risk of aplastic anemia and hepatic failure associated with felbamate, felbamate tablets are not indicated as a first-line treatment for epilepsy. The drug should be considered only for patients with severe epilepsy who respond inadequately to alternative treatments. Felbamate can be used alone or in combination with other antiepileptics to treat partial seizures in adults with epilepsy and children with Lennox-Gastaut syndrome. If felbamate tablets are added to or substituted for other AEDs, the dosage of each AED should be reduced by 20% to 33% to minimize side effects.

Dosage Form: Tablets: 400 and 600 mg

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Fluoxetine Tablets

Marketed by: Edgemont Pharmaceuticals (Austin, TX)

Compared to: Prozac (Eli Lilly)

Indication: Edgemont Pharmaceuticals announced the FDA approval of fluoxetine tablets in a 60-mg strength. Equivalent to Pfizer’s Prozac, fluoxetine is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder, obsessive compulsive disorder, bulimia nervosa, and panic disorder. Research shows 40% of patients taking antidepressants become nonadherent within 3 months of initiating therapy. By reducing the number of pills per 60-mg dose from 3 to 1, Edgemont’s 60-mg tablets are designed to improve adherence in patients who may have trouble remembering to take medications. The tablets are also functionally scored, allowing patients to take a 30-mg half dose as directed by a prescriber.

Dosage Form: Tablets: 60 mg

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Levetiracetam Oral Solution

Marketed by: Amneal Pharmaceuticals (Bridgewater, NJ)

Compared to: Keppra (UCB Pharma)

Indication: Amneal launched levetiracetam oral solution, a generic alternative to Keppra that is used to treat epileptic seizures in patients as young as 4 years old. Amneal’s version is also indicated in the treatment of myoclonic seizures in patients 12 years and older with juvenile myoclonic epilepsy, as well as primary generalized tonic-clonic seizures in patients 6 years and older with idiopathic generalized epilepsy. The clear, grape-flavored liquid is available in a 100-mg/mL strength and is supplied in 2 sizes: a standard 16-oz (473 mL) size and a new, smaller bottle containing 4 oz (118 mL) of the solution.

Dosage Form: Oral solution: 100 mg/mL

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Levetiracetam Extended-Release Tablets

Marketed by: Actavis (Morristown, NJ)

Compared to: Keppra XR (UCB Pharma)

Indication: Equivalent to Keppra XR, Actavis’ levetiracetam extended-release tablets are indicated as adjunctive therapy for the treatment of partial onset seizures in patients 16 years and older with epilepsy. The recommended initial dose is 1000 mg, taken once daily. The dosage may be increased by increments of 1000 mg every 2 weeks until the maximum recommended daily dose of 3000 mg is reached. Patients taking levetiracetam extended-release tablets should be advised not to chew, break, or crush the tablets and avoid driving or operating heavy machinery—at least until they are familiar with the drug’s effects, which may include sleepiness, fatigue, or loss of coordination.

Dosage Form: Extended-release tablets: 500 and 750 mg

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