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New branded Rxs, OTCs, home health care items, health & beauty, etc.
A new prescription drug product is now available for the treatment of seborrheic dermatitis and tinea versicolor of the skin. Tersi Foam, from Quinnova Pharmaceuticals, Newtown, Pa., contains 2.25% selenium sulfide as its active ingredient. It provides a leave-on foam to help reduce the Malassezia fungi that compromise a patient's natural skin barrier, resulting in inflammation, flaking, and redness. Quinnova can be reached at (215) 860-6263.
French firm Ipsen, through its partner Tercica, Brisbane, Calif., (650) 624-4900, is making available new FDA-approved Somatuline Depot (lanreotide) Injection-60, 90, and 120 mg/mL-in the United States. The product is indicated for the long-term treatment of acromegaly in patients who have responded inadequately to surgery and/or radiotherapy, or for whom those treatments are not an option.
Acambis plc, Cambridge, Mass., (617) 761-4200, has FDA approval for ACAM2000 (smallpox [vaccinia] vaccine, live) Vaccine for active immunization against smallpox in persons at high risk for the infection. The approval also looks ahead to use as preparedness against the threat of smallpox. This single-dose vaccine is the primary agent in the government stockpile for use in an emergency.
A.T.S. Pharmaceuticals, Los Angeles, (866) 287-4428, a division of Auriga Laboratories, is launching Xyralid Cream (lidocaine HCl 3%/hydrocortisone acetate 1%), a kit that also contains Cleré, a soap-free cleanser. This is the third product in the Xyralid line, which also includes Xyralid RC and Xyralid LP Lotion. The new kit is indicated for anti-inflammatory anesthetic relief of pruritus-including pruritic eczemas, abrasions, minor burns, insect bites, and other conditions of the skin and mucous membranes.
The FDA has approved updated prescribing information for Coumadin (warfarin sodium), a blood-thinning agent from Bristol-Myers Squibb, Princeton, N.J., (609) 252-4000. The labeling will explain that people's genetic makeup may influence their response to the drug. It is hoped that healthcare providers can use genetic tests to more accurately prescribe warfarin dosing for individual patients in order to lower the risk of bleeding complications.
MGI Pharma, Minneapolis, (952) 346-4700, has been granted a labeling change for Aloxi (palonosetron hydrochloride) Injection. Following results from several safety and efficacy trials evaluating multiple-day dosing of the agent, the label change permits the removal of a dosing recommendation that limited use of the product to once in every seven-day interval. Palonosetron hydrochloride is approved for prevention of the acute nausea and vomiting of initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.