Generic Product News

Pharmacy TimesFebruary 2013 Autoimmune Disorders
Volume 79
Issue 2

Atorvastatin Calcium Tablets

Marketed by: Greenstone LLC

Compare to: Lipitor (Pfizer, Inc)

Indication: Greenstone’s Atorvastatin Calcium tablets, an authorized generic equivalent of Lipitor, are indicated as an adjunct to diet to reduce the risk of stroke, myocardial infarction (MI), revascularization, and angina in patients without coronary heart disease (CHD) but with multiple risk factors; to reduce the risk of MI and stroke in patients with type 2 diabetes without CHD but with multiple risk factors; and to reduce the risk of certain cardiac and cerebrovascular events for patients with CHD. They are also indicated for patients with primary and secondary hyperlipidemias; see prescribing information for complete details.

Dosage Form: Tablets: 10, 20, 40, and 80 mg

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Candesartan Cilexetil/Hydrochlorothiazide Tablets

Marketed by: Par Pharmaceutical Inc

Compare to: Atacand HCT (AstraZeneca)

Indication: Par Pharmaceutical Inc has entered an exclusive US supply and distribution agreement with AstraZeneca to distribute an authorized generic version of Atacand HCT. Candesartan Cilexetil/Hydrochlorothiazide tablets are indicated for the treatment of hypertension, and combine an angiotensin II receptor blocker with a diuretic. This fixed-dose combination is not indicated for initial therapy. It is contraindicated in patients with sensitivity to any of the drug components, as well as in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Dosage Form: Tablets: 16/12.5, 32/12.5, and 32/25 mg

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Phenytoin Tablets, USP

Marketed by: Greenstone LLC

Compare to: Dilantin Infatabs (Pfizer, Inc)

Indication: Greenstone LLC announces the introduction of Phenytoin Tablets, USP, which is equivalent to Pfizer Inc’s Dilantin Infatabs. Phenytoin Tablets, USP, are an antiepileptic drug for the control of tonic-clonic and complex partial seizures. Dosage should be tailored to individual patients to provide maximum benefit, and the typical starting dose for a patient who has not received prior therapy is 2 tablets 3 times daily. Phenytoin tablets can either be chewed thoroughly when administered or swallowed whole.

Dosage Form: Tablet: 50 mg

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Pioglitazone Hydrochloride and Glimepiride Tablets

Marketed by: Sandoz Inc

Compare to: Duetact (Takeda Pharmaceuticals)

Indication: Sandoz announces the approval of Pioglitazone Hydrochloride and Glimepiride tablets. The tablets are a combination product to be used in addition to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus who are already being treated with certain diabetes medications, or who cannot adequately obtain glycemic control when using certain diabetes medications alone.

Dosage Form: Tablets: 30 mg/2 mg, and 30 mg/4 mg

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Tranexamic Acid Tablets

Marketed by: Prasco Laboratories

Compare to: Lysteda (Ferring Pharmaceuticals)

Indication: Prasco Laboratories began shipping Tranexamic Acid tablets, its authorized generic version of Ferring Pharmaceuticals’ Lysteda. The tablets are AB-rated and are indicated for the treatment of cyclic heavy menstrual bleeding. The recommended dosage for patients with normal renal function is two 650-mg tablets 3 times per day for a maximum of 5 days during monthly menstruation. Tablets do not need to be administered with meals, and should be swallowed whole. Dosage adjustment is needed for certain patients with renal impairment.

Dosage Form: Tablets: 650 mg

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Lamotrigene Extended-Release Tablets

Marketed by: Wockhardt

Compare to: Lamictal XR (GlaxoSmithKline)

Indication: The FDA gave final approval to Wockhardt to market Lamotrigine ExtendedRelease Tablets, an antiepileptic drug for adjunctive therapy for primary generalized tonic-clonic seizures and partial onset seizures with or without generalization in patients older than 13 years. The product carries a boxed warning against the risk of life-threatening skin rashes. It also carries a boxed warning for suicidal behavior and ideation and asceptic meningitis.

Dosage Form: Extended-release tablets: 25, 50, 100, 200, and 300 mg

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Quinine Sulfate Capsules USP

Marketed by: Teva Pharmaceuticals

Compare to: Qualacin (AR Scientific)

Indication: Teva Pharmaceuticals introduces Quinine Sulfate Capsules USP, an AB-rated bioequivalent product to AR Scientific’s Qualacin. The product is indicated for the treatment of uncomplicated Plasmodium falciparum malaria. Adults 16 years and older should take 648 mg every 8 hours for 7 days. For patients with severe chronic renal impairment, a loading dose of 648 mg is recommended, and should be followed 12 hours later by 324 mg every 12 hours for 7 days.

Dosage: Capsules: 324 mg

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