/publications/issue/2007/2007-06/2007-06-6546

rx PRODUCT news

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Actonel (risedronate sodium tablets)

Marketed by: The Alliance for Better Bone Health, a collaboration between Procter & Gamble Pharmaceuticals Inc (Cincinnati, Ohio) and sanofi-aventis US (Bridgewater, NJ)

Indication: April 16, 2007?The FDA approved a new dose for Actonel. The new approval will give patients the option of taking one Actonel 75-mg tablet on 2 consecutive days, for a total of 2 tablets monthly, to treat and prevent postmenopausal osteoporosis. Actonel has been proven to reduce the risk of both vertebral and nonvertebral fractures in postmenopausal women with osteoporosis. In postmenopausal women with osteoporosis, Actonel increases bone mineral density and reduces the incidence of vertebral fractures and a composite end point of nonvertebral osteoporosis-related fractures.
Dosage Form: Tablets: 75 mg (also 5, 30, and 35 mg)

For More Information: www.actonel.com


Altabax (retapamulin ointment), 1%

Marketed by: GlaxoSmithKline (Research Triangle Park, NC)

Indication: April 12, 2007?GlaxoSmithKline announced that the FDA approved its antibacterial Altabax for the topical treatment of impetigo due to susceptible strains of Staphylococcus aureus or Streptococcus pyogenes, the 2 most common types of bacteria in this type of infection. Altabax represents the first new class of prescription topical antibacterials to receive FDA approval in nearly 2 decades. Altabax is a new molecular entity not previously approved in the United States. The product is indicated for use twice daily for a 5-day period in patients aged 9 months and older.

Dosage form: 10 mg retapamulin/1 g ointment in 5-, 10-, and 15-g tubes

For more information: www.altabax.com


Conceivex Conception Kit

Marketed by: Conceivex Inc (Saranac, Mich)

Indication: March 23, 2007? Conceivex Inc announced that the FDA granted 510(k) clearance for its Conceivex Conception Kit. The kit is the first and only FDA-cleared reproductive health care system designed for couples to use in the privacy of their own home. It contains a 3-month supply of conception caps, as well as conception-related information, 3 nonlatex semen collectors, 24 ovulation predictors, 2 conception-timing wheels, 3 pregnancy test kits, 3 packages of intimate moisturizer, a medical provider note, an instruction manual, and a journal to record an individual?s progress. The items are designed to be used together for up to 3 months in order to enhance a couple?s chance of conception.

For more information: www.conceptionkit.com


Coreg CR(carvedilol phosphate)

Marketed by: GlaxoSmithKline (Research Triangle Park, NC)

Indication: March 22, 2007?GlaxoSmithKline announced that Coreg CR extended-release capsules are now available in pharmacies nationwide. Coreg, a once-a-day ?-blocker, is approved by the FDA to treat 3 cardiovascular conditions: (1) hypertension; (2) post?myocardial infarction left ventricular dysfunction; and (3) mild-to-severe heart failure. The availability of this once-a-day formulation allows patients, who previously had to take Coreg twice a day, to take fewer pills.

Dosage Form: Capsules: 10, 20, 40, and 80 mg

For More Information: www.coregcr.com 888-825-5249


Niaspan (niacin extended-release tablets)

Marketed by: Abbott Laboratories (Abbott Park, Ill)

Indication: April 6, 2007?The FDA has approved Abbott?s new coated Niaspan tablet. Niaspan, the only FDA-approved, once-daily extended-release prescription niacin formulation, is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures has been inadequate for the treatment of lipid disorders with an ability to raise high-density lipoprotein cholesterol (?good? cholesterol). The product also is indicated for the secondary prevention of heart attacks, and in combination with a bile acid binding resin it is indicated to promote regression of coronary atherosclerosis in patients with a history of coronary artery disease.

Dosage form: Tablets: 500, 750, and 1000 mg

For more information: www.rxabbott.com/pdf/niaspan.pdf 800-633-9110


Singulair (montekulast sodium)

Marketed by: Merck & Co Inc (Whitehouse Station, NJ)

Indication: April 25, 2007?Merck & Co announced that the FDA approved an additional indication for Singulair to prevent exercise-induced bronchoconstriction (EIB; also called exercise-induced asthma) in patients aged 15 years and older. This represents the first and only oral tablet approved for EIB, which is characterized by shortness of breath, cough, wheeze, and chest tightness brought on by exercise. In addition to this new indication, Singulair is an option for the prevention and chronic treatment of asthma in adults and pediatric patients aged 12 months and older.

Dosage form: Tablets: 4, 5, and 10 mg; 4-mg oral granules

For more information: www.singulair.com 800-633-9110


Janumet (sitagliptin/ metformin HCl)

Marketed by: Merck & Co Inc (Whitehouse Station, NJ)

Indication: April 2, 2007?Merck & Co announced that the FDA approved Janumet, the first and only tablet to combine a dipeptidyl peptidase-4 inhibitor, sitagliptin (Januvia), and metformin for the treatment of type 2 diabetes. Janumet is indicated as an adjunct to diet and exercise to improve glucose control in adult patients with type 2 diabetes who are not adequately controlled on metformin or sitagliptin alone, or in patients who are already being treated with the combination of sitagliptin and metformin. Janumet should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

Dosage Form: Tablets: 50 mg sitagliptin/500 mg metformin HCl, 50 mg sitagliptin/1000 mg metformin HCl

For More Information: www.janumet.com


Tykerb (lapatinib)

Marketed by: GlaxoSmithKline (Research Triangle Park, NC)

Indication: March 13, 2007?GlaxoSmithKline announced that the FDA approved Tykerb, in combination with Xeloda (capecitabine), for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. It is the first targeted, once-daily oral treatment option for this population. The recommended dose of Tykerb is 1250 mg (5 tablets) given orally once daily on days 1 through 21 continuously in combination with capecitabine 2000 mg/m(2)/day (administered orally in 2 doses ~12 hours apart) on days 1 through 14 in a repeating 21-day cycle.

Dosage form: Tablets: 250 mg

For more information: www.tykerb.com 866-4-TYKERB (866-489-5372)