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New medicines debut in U.S. market.

WASHINGTON -- Greenstone LLC has introduced olanzapine tablets in 2.5-, 5-, 7.5-, 10-, 15- and 20-mg dosage strengths. The product from Greenstone, a subsidiary of Pfizer Inc., is the generic version of Zyprexa.

Other manufacturers have also launched new generics. Mylan Pharmaceuticals ULC has received approval from Health Canada for Mylan-Bosentan tablets, 62.5 mg and 125 mg. Mylan-Bosentan is the generic version of Actelion Pharmaceuticals Ltd.'s Tracleer, used for the treatment of pulmonary arterial hypertension.

Perrigo Co. received final approval from the Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for calcium acetate capsules, the generic equivalent of Phoslo Gelcaps. Perrigo was previously in patent litigation over this product with the brand; the litigation was settled in late 2011.

Terms of the settlement are confidential.

Phoslo Gelcaps are indicated for hyperphosphatemia in patients with end-stage kidney disease who are on dialysis.

Sandoz has introduced voriconazole injection, the first generic version of Pfizer's Vfend, in the United States.

Voriconazole injection is indicated for use in patients 12 and older in the treatment of certain serious fungal infections of the blood and body.

Teva Pharmaceutical Industries Ltd. has launched olanzapine and fluoxetine capsules USP 6 mg/25 mg, 12 mg/25 mg, 6 mg/50 mg and 12 mg/50 mg, the company's generic equivalent of Symbyax.

Symbyax is marketed by Lilly USA and is approved for the acute treatment of treatment-resistant depression and bipolar I depression in adults. The brand product had annual sales of around $82 million in the United States, based on IMS sales data.

Dr. Reddy's Laboratories has launched ropinirole hydrochloride XR (extended-release) tablets (2 mg, 4 mg, 6 mg, 8 mg and 12 mg), a bioequivalent generic version of Requip XL tablets in the United States.

The brand had U.S. sales of about $58 million for the 12 months ended March 2012, according to IMS Health.

Dr. Reddy's ropinirole hydrochloride XR tablets in 2 mg, 4 mg and 6 mg are available in 30- and 90-count bottle sizes; 8 mg and 12 mg are available in 30-count sizes.

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Title Annotation:RX: RETAIL PHARMACY: Generic Drugs
Publication:Chain Drug Review
Date:Jul 16, 2012
Words:348
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