Rx Product News

Pharmacy Times
Volume 0

Atripla (efavirenz/emtricitabine/ tenofovir disoproxil fumarate)

Marketed by: Bristol-Myers Squibb Co (Princeton, NJ) and Gilead Sciences Inc (Foster City, Calif)

Indication: July 12, 2006?Bristol-Myers Squibb Co and Gilead Sciences Inc announced FDA approval of Atripla for the treatment of HIV-1 infection in adults. Atripla combines Sustiva (efavirenz), manufactured by Bristol-Myers Squibb, and Truvada (emtricitabine and tenofovir disoproxil fumarate), manufactured by Gilead Sciences, into 1 tablet. This product is the first-ever once-daily single-tablet regimen for HIV intended as a stand-alone therapy or in combination with other antiretrovirals.

Dosage Form: Each tablet contains 600 mg efavirenz, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate.

For More Information: www.atripla.com 888-547-4267

BenzaClin (clindamycin 1%-benzoyl peroxide 5% gel) Topical Gel

Marketed by: Dermik Laboratories, a business of sanofiaventis US LLC (Bridgewater, NJ)

Indication: July 31, 2006?Dermik Laboratories announced the commercial availability of the BenzaClin pump 50-g Topical Gel. It is the newest dispensing option and the only combination acne treatment in a pump form, available to patients for the treatment of mild-to-moderate acne. BenzaClin is the only clindamycin/ benzoyl peroxide gel that is FDA-approved for both inflammatory and noninflammatory lesions. It also has been proven to demonstrate results in as little as 2 weeks.

Dosage Form: Gel: 25-and 50-g jar, 50-g pump

For More Information: www.benzaclin.com 800-207-8049

Cesamet (CII) (nabilone)

Marketed by: Valeant Pharmaceuticals International (Costa Mesa, Calif)

Indication: May 15, 2006?Valeant Pharmaceuticals International received marketing approval from the FDA for Cesamet (CII) oral capsules. Cesamet is indicated for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Dosage Form: Capsules: 1 mg

For More Information: www.valeant.com 877-361-2719

Famvir (famciclovir)

Marketed by: Novartis Pharmaceuticals Corp (East Hanover, NJ)

Indication: July 28, 2006?Novartis announced FDA approval of Famvir tablets as a single-day treatment for immunocompetent patients with recurrent genital herpes (RGH), based on a supplemental new drug application. Famvir was shown to significantly reduce the healing time of nonaborted lesions, as well as the time to resolution of studied symptoms in RGH patients with lesions, by almost 2 days. The FDA also approved Famvir as a single-dose treatment for recurrent herpes labialis (cold sores) in immunocompetent patients.

Dosage Form: Tablets: 125, 250, and 500 mg

For More Information: www.famvir.com 888-NOW-NOVA (888-669-6682)

Humira (adalimumab)

Marketed by: Abbott Laboratories (Abbott Park, Ill)

Indication: July 31, 2006?Abbott announced that the FDA has approved Humira for an additional indication: the reduction of signs and symptoms in patients with active ankylosing spondylitis. Humira is also FDA-approved to treat rheumatoid arthritis and psoriatic arthritis. Humira is available for self-administration through the new delivery device, the Humira pen, approved by the FDA on June 23, 2006. The new Humira pen offers improved ease of use and a less-painful experience, compared with the Humira prefilled syringe.

Dosage Form: Subcutaneous injection: 40 mg

For More Information: www.humira.com 800-4HUMIRA (800-448-6472)

Implanon (etonogestrel implant)

Marketed by: Organon (Roseland, NJ)

Indication: July 18, 2006?Organon announced that the FDA has approved Implanon, the first and only single-rod implantable contraceptive that is effective for up to 3 years. Implanon is made of a soft medical polymer and is inserted just beneath the skin on the inner side of a woman's upper arm by a health care provider during an in-office procedure. It continually releases a low, steady dose of progestin (etonogestrel) for a period of up to 3 years via a unique implantable technology.

Dosage Form: Implant: Average hormone release rate 40 mcg/day

For More Information: www.implanon-usa.com 877-IMPLANON (877-467-5266)

Limbrel (flavocoxid)

Marketed by: Primus Pharmaceuticals Inc (Scottsdale, Ariz)

Indication: August 3, 2006?Primus Pharmaceuticals Inc announced a new, increased dosage formulation of Limbrel, the first prescription product developed to safely meet the distinctive nutritional requirements of patients with osteoarthritis. Limbrel will now be available at an increased level of 500 mg, in addition to the standard 250-mg capsule form, as a result of a growing demand for the medical food.

Dosage Form: Capsules: 250 and 500 mg

For More Information: www.limbrel.com

Lotrel (amlodipine besylate/benazepril HCl)

Marketed by: Novartis Pharmaceuticals Corp (East Hanover, NJ)

Indication: June 9, 2006?Novartis announced that it received marketing approval from the FDA for 2 new dosage formulations of Lotrel, 5/40 mg and 10/40 mg. The new dosage strengths combine the calcium channel blocker amlodipine with the highest available dose of the angiotensin-converting enzyme (ACE) inhibitor benazepril. These new dosage formulations provide greater dosing flexibility for previously uncontrolled patients who need powerful blood pressure lowering with the benefits of the higher-dose ACE inhibitor.

Dosage Form: Capsules: 2.5/10, 5/10, 5/20, 10/20, 5/40, and 10/40 mg

For More Information: www.lotrel.com 888-NOW-NOVA (888-669-6682)

Chantix (varenicline)

Marketed by: Pfizer Inc (New York, NY)

Indication: August 1, 2006?Pfizer announced that Chantix is now available in US pharmacies. Originally approved by the FDA in May 2006, Chantix is the first new prescription aid to smokingcessation treatment approved by the FDA in nearly a decade. Chantix represents a breakthrough treatment developed to block the effect of nicotine in the brain and to aid those patients who are trying to overcome nicotine addiction, a chronic medical condition.

Dosage Form: Tablets: 0.5 and 1 mg

For More Information: www.chantix.com 877-CHANTIX (877-242-6849)

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