New Rx, OTC, and generics (October 2010)


A survey of new Rx, new generic, and new OTC products

Key Points


New drugs

FDA has approved Shionogi's Cuvposa (glycopyrrolate) Oral Solution, a flavored oral solution, to treat chronic severe drooling caused by neurologic disorders in children aged 3 to 16 years. (800-461-3696)

GlaxoSmithKline has shipped the 2010–2011 formulation of FluLaval and and anticipates distributing Fluarix; both are trivalent, inactivated, "split virus" influenza vaccines (Types A and B) and will include the 2009 H1N1 pandemic strain among the 3 vaccine strains. (

Sanofi Pasteur's 2010–2011 formulation of Fluzone (trivalent inactivated "split virus" influenza vaccine [Types A and B]) has shipped. It includes the 2009 H1N1 pandemic strain among the 3 vaccine strains. (

Labopharm and Angelini have launched Oleptro (trazodone HCl extended-release tablets) for the treatment of major depressive disorder (MDD) in adults. The 150-mg and 300-mg tablets are scored and may be halved without compromising the tablets' extended-release properties. (

Mission Pharmacal's prescription Uribel capsules (methenamine, sodium phosphate monobasic, phenyl salicylate, methylene blue, hyoscyamine sulfate) help relieve local discomfort and inflammation associated with lower urinary tract infections, interstitial cystitis, painful bladder syndrome, and pre- and postdiagnostic urinary tract procedures. Symptom relief can begin within 30 minutes. (

New generic

FDA has approved Lannett's ANDA for Phentermine Hydrochloride Blue/White Seed Capsules USP, 30 mg (the generic equivalent of Sandoz, Inc.'s Phentermine Hydrochloride capsules USP, 30 mg), a short-term adjunct in a regimen of weight reduction in the management of exogenous obesity in the presence of other risk factors, such as hypertension, diabetes, and hyperlipidemia. (800-325-9994/215-333-9000)


Carma Laboratories has expanded its line of Carmex products with the launch of Carmex Healing Lotion and Carmex Healing Cream. The lotion, a moisturizer for daily use, contains allantoin 0.5%, aloe, and vitamin E. The cream is a more concentrated formula for use on extremely dry, cracked skin. (

New from Blistex is Blistex Five Star Lip Protection, a lip balm that includes natural essential oils, extracts, and 4 sunscreens that provide broad spectrum SPF 30 UVA/UVB sun protection. (

Truceuticals, makers of Noxicare Natural Pain Relief Cream, now offers a dietary supplement, Noxicare Natural Pain Relief Tablets. The 60-tablet bottles contain antioxidant-rich ingredients such as turmeric, willow bark, ginger, holy basil, rosemary extract, boswellia extract, and alpha lipoic acids, known to reduce chronic pain and inflammation while promoting overall joint and body health. (877-669-4227/

Johnson & Johnson's alcohol-free Listerine Zero freshens breath with the same ingredients found in regular Listerine Antiseptic. (

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