New product newswire: August 7, 2006

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NEW DRUGS

GlaxoSmithKline, Research Triangle Park, N.C., (919) 483-2100, has received approval for Advair HFA (fluticasone propionate and salmeterol xinafoate inhalation aerosol). The product is indicated for the treatment of asthma in patients age 12 and older. It is used long-term, twice a day, and is not to be used as a short-acting bronchodilator.

NEW INDICATIONS

GlaxoSmithKline has been granted approval for two new drug indications. Avandamet (rosiglitazone maleate and metformin HCl) can now be used as initial treatment for Type 2 diabetes. The drug was approved earlier as second-line therapy for Type 2 diabetes patients inadequately controlled on metformin monotherapy. Hycamtin (topotecan HCl) for Injection, 4 mg, in combination with cisplatin, is now indicated for the treatment of stage IV-B, recurrent, or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy. The drug was approved earlier for treatment of ovarian cancer and small cell lung cancer unresponsive to other chemotherapy.

Revlimid (lenalidomide), from Celgene, Summit, N.J., has been granted an extended indication. It can now be used in combination with dexamethasone to treat patients with multiple myeloma who have received at least one prior therapy. Because the drug can cause life-threatening birth defects in humans, it is available only under a restricted distribution program. Revlimid was approved earlier for certain patients with transfusion-dependent anemia. Celgene can be reached at (908) 673-9000.

NEW PRESENTATION

Also from GlaxoSmithKline, Ventolin HFA (albuterol sulfate HFA inhalation aerosol) is now available as a metered-dose inhaler with an integrated dose counter. Ventolin HFA with dose counter helps patients and their doctors accurately track albuterol use as an indicator of uncontrolled asthma. The bronchodilator is used as a rescue inhaler to treat sudden symptoms of asthma, including coughing, wheezing, and shortness of breath.

NEW DOSAGE STRENGTHS

Toward more flexible dosing for the control of blood pressure, Novartis Pharmaceuticals, East Hanover, N.J., (862) 778-8300, is providing two new strengths of its hypertension medication Lotrel (amlodipine besylate/benazepril HCl). The combination calcium-channel blocker/ACE inhibitor is now available in the higher doses of 5/40 mg and 10/40 mg. The drug is also available in four other strengths.

NOW AVAILABLE

Vivitrol (naltrexone for extended-release injectable suspension), a once-monthly medication for alcohol dependence, is now available in the United States. Vivitrol is the product of Cephalon Inc., Frazer, Pa., (610) 344-0200, and Alkermes, Cambridge, Mass., (617) 494-0171. It is indicated as part of a comprehensive treatment management program for patients who are able to abstain from drinking in an outpatient setting and who are not actively drinking when initiating treatment.