Generic Product News

Pharmacy TimesJuly 2013 Digestive Health
Volume 79
Issue 7

Marketed by: Dr. Reddy’s Laboratories

Compare to: Accutane (Hoffmann-La Roche)

Indication: Dr. Reddy’s Laboratories has launched Zenatane (isotretinoin capsules USP), a therapeutically equivalent generic version of Accutane. To avoid a high risk of birth defects, Zenatane is not indicated for female patients who are or may become pregnant, and it is approved for marketing only under a restricted FDA-approved distribution program called iPLEDGE. Zenatane should be discontinued if pregnancy occurs, and patients should be referred to an obstetrician-gynecologist experienced in toxicity.

Dosage Form: Capsules: 10 mg, 20 mg, 40 mg

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Marketed by: Perrigo Company

Compare to: Sanctura XR (Allergan)

Indication: Perrigo Company has received final approval for the generic version of Sanctura XR. It is indicated for the treatment of overactive bladder symptoms, including urge urinary incontinence, urgency, and urinary frequency. Trospium Chloride Extended-Release Capsules are available as a once-daily, 60-mg dose that should be taken in the morning at least 1 hour before eating. The product has begun shipping.

Dosage Form: Capsules: 60 mg

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Sildenafil Tablets

Marketed by: Teva Pharmaceuticals

Compare to: Revatio (Pfizer Inc)

Indication: Teva Pharmaceuticals is pleased to announce the introduction and availability of sildenafil tablets. This product is AB rated and bioequivalent to Revatio Tablets. It is indicated for the treatment of pulmonary arterial hypertension in adults to improve exercise ability and delay clinical worsening. The recommended dose is a 20-mg tablet 3 times a day, taken 4 to 6 hours apart. Sildenafil tablets are available in 20-mg strength, in bottle sizes of 90.

Dosage Form: Tablets: 20 mg

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Marketed by: Ranbaxy Pharmaceuticals, Inc

Compare to: Pristiq (Pfizer Inc)

Indication: Ranbaxy Pharmaceuticals Inc entered an in-licensing agreement with Alembic Pharmaceuticals Limited to exclusively market desvenlafaxine base extendedrelease tablets in the United States. Alembic Pharmaceuticals Limited sponsored the new drug application for the product and is the manufacturer. The product is indicated for the treatment of major depressive disorder and is bioequivalent to Pfizer Inc’s Pristiq.

Dosage Form: Tablets: 50 mg, 100 mg

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