Generic Products

MARCH 18, 2012

FenoFibrate Tablets

Marketed by: Lupin Pharmaceuticals Inc (Baltimore, MD)

Compared to: TriCor (Abbott Laboratories)

Indication: The FDA approved Lupin Pharmaceuticals Inc’s Fenofibrate Tablets, which are an AB-rated equivalent to Abbott’s TriCor tablets. Fenofibrate Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol, total cholesterol, triglycerides, and apolipoprotein B and to elevate high-density lipoprotein in adult patients with primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate Tablets are also indicated for the management of severe hypertriglyceridemia in adult patients.

Dosage Form: Tablets: 48 and 145 mg

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Progesterone Capsules

Marketed by: Teva Pharmaceuticals (North Wales, PA)

Compared to: Prometrium Capsules (Solvay Pharmaceuticals Inc)

Indication: Progesterone Capsules are indicated for the prevention of endometrial hyperplasia in postmenopausal women who have not undergone hysterectomy and who are taking conjugated estrogen tablets. They are also indicated for secondary amenorrhea. Progesterone Capsules are AB rated and bioequivalent to Prometrium Capsules. For the prevention of endometrial hyperplasia, Progesterone Capsules may be taken as a single dose of 200 mg at bedtime for 12 days sequentially per 28-day cycle. For treatment of secondary amenorrhea, they may be taken as a single 400-mg dose at bedtime for 10 days.

Dosage Form: Capsules: 100 and 200 mg

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Carbamazepine extended-release Capsules

Marketed by: Prasco Laboratories (Cincinnati, OH)

Compared to: Carbatrol (Shire US Inc)

Indication: Prasco reached an agreement with Shire to distribute the AB-rated and therapeutically equivalent authorized generic version of Carbatrol. Carbamazepine Extended-Release Capsules are indicated as anticonvulsant therapy in patients with partial seizures with complex symptomatology, tonic-clonic seizures, or mixed-pattern seizures. It is also indicated for the treatment of the pain associated with trigeminal neuralgia. Carbamazepine Extended-Release Capsules carry a boxed warning against serious skin reactions and aplastic anemia and agranulocytosis.

Dosage Form: Extended-release capsules: 100, 200, and 300 mg

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Felbamate Oral Suspension

Marketed by: Amneal Pharmaceuticals, LLC (Bridgewater, NJ)

Compared to: Felbatol (Meda Pharmaceuticals)

Indication: Amneal Pharmaceuticals, LLC, announced the availability of the first felbamate oral suspension in a 600-mg/5- mL strength. AB rated and therapeutically equivalent to the antiepileptic Felbatol, Felbamate Oral Suspension is a pink, bubble gum flavored liquid that does not require refrigeration. The product carries a boxed warning against the possibility of aplastic anemia and hepatic failure. Felbamate Oral Suspension is available in 2 sizes: 8 fl oz (240 mL) and 16 fl oz (473 mL).

Dosage Form: Oral suspension: 600 mg/5 mL

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Escitalopram Tablets, USP

Marketed by: Mylan Pharmaceuticals Inc (Pittsburgh, PA)

Compared to: Lexapro (Forest Laboratories)

Indication: Mylan Pharmaceuticals Inc has launched the first equivalent product to Forest Laboratories’ Lexapro. Escitalopram Tablets, USP, are indicated for the acute and maintenance treatment of major depressive disorder in adults and children aged 12 to 17 years as well as the acute treatment of generalized anxiety disorder in adults. Escitalopram Tablets carry a boxed warning against an increased risk in suicidal thoughts and behaviors. They are not indicated for patients younger than 12 years.

Dosage Form: Tablets: 5, 10, and 20 mg

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VoriConazole tablets

Marketed by: Sandoz (Princeton, NJ)

Compared to: Vfend (Pfizer Inc)

Indication: Voriconazole Tablets are a triazole antifungal drug indicated for use in the treatment of invasive aspergillosis; candidemia in nonneutropenic patients, and disseminated candidiasis in skin, abdomen, kidney, bladder wall, and wounds; esophageal candidiasis; and serious infections caused by Scedosporium apiospermum and Fusarium species, including Fusarium solani, in patients intolerant of or refractory to other therapy. Voriconazole Tablets are pregnancy category D and should not be administered to pregnant or nursing women. Safety and efficacy have not been determined in patients younger than 12 years.

Dosage Form: Tablets: 50 and 200 mg

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Olanzapine Orally Disintegrating Tablets

Marketed by: Teva Pharmaceuticals (North Wales, PA)

Compared to: Zyprexa Zydis (Eli Lilly & Co)

Indication: Olanzapine Orally Disintegrating Tablets (ODT) are an AB-rated and bioequivalent generic version of Eli Lilly & Co’s Zyprexa Zydis. Olanzapine ODT is an atypical antipsychotic indicated for the treatment of schizophrenia or mixed or manic episodes of bipolar I disorder or for the treatment of depressive episodes of bipolar I disorder as an adjunct to valproate or lithium. It carries a boxed warning against the risk of increased mortality in elderly patients with dementia-related psychosis.

Dosage Form: Orally disintegrating tablets: 5, 10, 15, and 20 mg

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Methylphenidate Hydrochloride Extended-release Capsules (la) CII, USP

Marketed by: Actavis (Morristown, NJ)

Compared to: Ritalin LA (Novartis Pharmaceuticals)

Indication: Actavis announced the approval of their Methylphenidate Hydrochloride Extended-Release Capsules (LA) CII by the FDA. Actavis has first-to-file exclusivity on the 20-, 30-, and 40-mg strengths of this generic equivalent to Ritalin LA. Methylphenidate Hydrochloride Extended-Release Capsules (LA) CII are a central nervous system stimulant indicated for the treatment of attention-deficit/hyperactivity disorder. They may be taken orally once daily in the morning, or the contents of the capsule can be sprinkled on a small amount of applesauce.

Dosage Form: Tablets: 20, 30, and 40 mg

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