Generic Product News

Pharmacy TimesDecember 2011 Heart Health
Volume 77
Issue 12

Marketed by: Amneal Pharmaceuticals (Bridgewater, NJ)

Compared to: DermOtic and Derma-Smoothe/FS (Hill Dermaceuticals)

Indication: Amneal introduced its first family of topical products, the new fluocinolone acetonide 0.01% oil line of prescription ear drops, body oil, and scalp oil. Amneal’s line is composed of fragrance-free, first-to-market generic versions of Hill Dermaceuticals’ otic and topical corticosteroids. Fluocinolone acetonide 0.01% is a low- to medium-potency corticosteroid that is used to treat atopic dermatitis and eczematous external otitis. Each of Amneal’s products is packaged in unit-of-dose cartons with the required accessories, including a pipette for the ear drops and 2 shower caps for the scalp oil. The scalp and body oils are sold in 4-oz/118-mL bottles with pop-up pour caps; the ear drops are supplied in a 1-oz/20-mL bottle.

Dosage Form: 1 g of fluocinolone acetonide 0.01% oil contains 0.11 mg fluocinolone acetonide in a blend of oils.

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Marketed by: Actavis (Morristown, NJ)

Compared to: Kadian (Actavis)

Indication: Actavis launched an authorized generic version of Kadian, its controlled-release opioid analgesic. Morphine sulfate extended-release capsules, USP CII, are indicated when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. They are not intended for use on an as-needed basis, or to treat pain that is mild or not expected to persist. As with any potent opioid, dosing should be individualized for each patient based on his or her experience with analgesic treatment. The 100-mg and 200-mg capsules are for use in opioid-tolerant patients only.

Dosage Form: Extended-release capsules: 10, 20, 30, 50, 60, 80, 100, and 200 mg

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

Compared to: Zyprexa Zydis (Eli Lilly)

Indication: Dr. Reddy’s launched an orally disintegrating formulation of olanzapine in strengths of 5, 10, 15, and 20 mg. Pharmacists should note that both the orally disintegrating tablets and standard formulations of olanzapine must be dispensed with a Medication Guide informing patients of the drug’s potential risks and adverse reactions, which include hyperlipidemia, hyperglycemia, and weight gain.

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

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Marketed by: Teva Pharmaceuticals (North Wales, PA) and Dr. Reddy’s Laboratories (Hyderabad, India)

Compared to: Zyprexa (Eli Lilly)

Indication: Teva and Dr. Reddy’s announced the launch of olanzapine tablets, the generic version of Zyprexa. The FDA awarded 180 days of marketing exclusivity to Teva for olanzapine tablets in the 2.5-mg, 5-mg, 7.5-mg, 10-mg, and 15-mg strengths, and to Dr. Reddy’s for olanzapine tablets in the 20-mg strength. Per an April 2011 agreement between the companies, Dr. Reddy’s is supplying the 20-mg strength to Teva and will launch its version of the additional strengths at the end of the exclusivity period. Olanzapine is an atypical antipsychotic used to treat schizophrenia in patients 13 years and older. It is also indicated alone, in combination with fluoxetine, or as adjunctive therapy to valproate or lithium in the treatment of bipolar disorder.

Dosage Form: Tablets: 2.5, 5, 7.5, 10, and 15 mg (Teva); 20 mg (Dr. Reddy’s)

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