Drug Topics - February 25, 2008 - (Page 7)

7 New Products > > > Rx NEW GENERICS Paddock Laboratories, www.paddocklabs.com, has introduced three products. Testosterone cypionate injection, USP is AO rated to Upjohn’s DepoTestosterone Injection and is available in 200 mg/mL in 1-mL and 10-mL glass vials. The product, for intramuscular injection, is indicated as replacement therapy in conditions associated with symptoms of endogenous testosterone deficiency or absence in the male. Neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP is an AT-rated antiinflammatory otic solution. Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP is an AT-rated antimicrobial solution. From Teva, www.tevausa.com, comes a generic version of Roche’s injectable antibiotic Rocephin. Ceftriaxone for injection, USP is a firstline agent used for a wide range of acute infections, among them community-acquired pneumonia. The injections are available in single-dose glass vials of 250 mg, 500 mg, 1 gm, and 2 gm. It also is available in a multi-dose 10-gm vial. Teva, Roxane (www.roxane.com), and Barr Labs (www.barrlabs.com) have received approval for the antiemetic granisetron hydrochloride, the generic version of Roche’s Kytril Injection, whose patent expired at the end of 2007. The selective blocking agent of the serotonin 5-HT3 receptor, was first approved in 1999, and is indicated for both prevention and treatment of postoperative nausea and vomiting. Teva offers both an injection that is available in 0.1mg/mL and 1mg/mL strengths as well as 1-mg tablet. Barr offers the medication in the 1-mg tablet form. The FDA also approved the applications from Roxane and Mylan, www.mylan.com, for balsalazide disodium, 750-mg capsules. The drug is the generic equivalent of Colazal from Salix Pharmaceuticals and is indicated for the treatment of mildly to moderately active ulcerative colitis in patients five years and older. Two companies have also received approval to sell generic ipratropium bromide and albuterol sulfate inhalation solution alternatives to Dey’s DuoNeb. The drug is indicated for the treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) in patients requiring more than one bronchodilator. Both Teva and Watson Pharmaceuticals, www.watson.com, will offer the inhalation solution in the 0.5-mg/3-mg strength. Watson has also received approval to launch clarithromycin extended-release 500-mg tablets, USP.The medication is the equivalent of Biaxin XL from Abbott and is indicated for the treatment and prevention of infections that are proven or strongly suspected of being caused by susceptible bacteria. AmerisourceBergen’s American Health Packaging, www.healthpack.com, has introduced two new medications. Finasteride tablets, in 5-mg strength, is an AB-rated generic alternative to Merck’s 5-mg Proscar. The drug is used for the treatment of symptomatic benign prostatic hyperplasia in men with enlarged prostate to reduce the need for surgery. The anti-anxiety medication Oxazepam CIV 10-, 15-, and 30-mg capsules is AB-rated to Serax. The FDA has approved the application for Caraco Pharmaceutical Laboratories, www.caraco.com, to launch glipizide/metformin tablets in 2.5/ 250mg, 2.5/500mg, and 5/500mg strengths. This introduction will provide patients with an alternative to Bristol-Myers Squibb’s Metaglip. The new generic is indicated for initial therapy—as an adjunct to diet and exercise—to improve glycemic control in Type 2 diabetes where diet and exercise are not sufficient. OTC The FDA has approved the production of cetirizine hydrochloride tablets from eight companies. The generic equivalent of Pfizer’s blockbuster Zyrtec antihistamine will be available from Par, Mylan, Ranbaxy, Sandoz, Caraco, Apotex, Actavis, and Wockhardt. Fasprin is a new product from Improvita, www.improvita.com, that allows the 81-mg pills of aspirin to dissolve in the mouth and immediately enter the bloodstream. The product will be available in a sugar-free citrus flavor. American Generic Laboratories has reintroduced Metabothin B56, www.metabothin.net, an herbal weight loss formula that includes ephedra extract. The product was pulled from the market in 2006, and, according to the company, is not subject to the final FDA rule regarding weight loss products containing ephedra alkaloids. DT http://www.watson.com http://www.paddocklabs.com http://www.healthpack.com http://www.tevausa.com http://www.caraco.com http://www.roxane.com http://www.barrlabs.com http://www.mylan.com http://www.improvita.com

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Contents Top 200 OTCs/HBCs in 2007 Clinical Pharmacists Advance into All Areas of Medical Treatment New Products Latest News Roundup

Drug Topics - February 25, 2008

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