New products: Rx, generics, OTC (August 2008)


New drugs, dosage, indications, generics, and over-the-counter products for sale in pharmacies.


New Drug

Sirion Therapeutics Inc. ( received FDA approval for Durezol (difluprednate ophthalmic emulsion) 0.05%, a topical steroid for the treatment of postoperative ocular inflammation and pain. The approval came after a six-month priority review. Sirion plans to make Durezol commercially available later this year.

Eisai Corp. of North America (, a wholly owned subsidiary of Tokyo-based Eisai Co. Ltd., received FDA approval for ACIPHEX (rabeprazole sodium) 20 mg for the short-term treatment (up to eight weeks) of gastroesophageal reflux disease (GERD), including heartburn, in adolescents ages 12 and older. The safety and effectiveness of ACIPHEX has not been established for children under the age of 12.

New Indication

GlaxoSmithKline ( announced FDA approval for AVODART (dutasteride) in combination with tamsulosin for the treatment of symptomatic enlarged prostate. The approval was based on two-year results of the CombAT (Combination of Avodart and Tamsulosin) study, one of the largest clinical trials to date of men with enlarged prostate.

New Generics

Teva Pharmaceuticals ( is making available its Ramipril Capsules. The product is AB rated and bioequivalent to Altace Capsules. Ramipril Capsules are available in 2.5-mg, 5-mg, and 10-mg strengths, in bottle sizes of 100.

The FDA approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions. The labeling of the generic risperidone may differ from that of Risperdal because some uses of the drug are protected by patents and exclusivity. Janssen (, a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., has launched an authorized generic version of Risperdal through Patriot Pharmaceuticals LLC.

Parenta Pharmaceuticals (, the U.S. subsidiary of Austria-based Ebewe Pharma, launched Granisetron Hydrochloride Injection, the generic equivalent of Hoffmann-La Roche's Kytril. The company will supply Granisetron Hydrochloride in AP-rated, bar-coded, latex-free vials in the following presentations: 0.1 mg/mL and 1 mg/mL single-dose vials and 4 mg/4mL (1 mg/mL) multidose vials. Granisetron Hydrochloride Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.

Watson Pharmaceuticals Inc. ( announced that, under a supply agreement with Solvay Pharmaceuticals Inc. (, it has launched the authorized generic version of dronabinol in the 2.5, 5, and 10 mg once-daily dosage strengths. Dronabinol is the generic version of Solvay Pharmaceuticals' MARINOL CIII Capsules, indicated to treat nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol is also indicated to treat anorexia associated with weight loss in patients with AIDS.

The FDA granted final approval to Caraco Pharmaceutical Laboratories Ltd. ( for its Abbreviated New Drug Applications (ANDAs) for the antidepressant Amitriptyline Hydrochloride USP Tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg. Amitriptyline's use is indicated to treat symptoms of depression.

Teva Pharmaceutical Industries ( announced that it has begun commercially shipping BupropionHydrochloride Extended-Release Tablets, 150 mg, the generic version of Biovail Corp.'s antidepressant Wellbutrin XL Tablets, pursuant to its March 2007 agreement with Anchen Pharmaceuticals Inc.

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