Rx Product News

Amitiza (lubiprostone)

Marketed by: Sucampo Pharmaceuticals Inc (Bethesda, Md) and Takeda Pharmaceuticals North America Inc (Lincolnshire, Ill)

Indication: April 25, 2006?Sucampo Pharmaceuticals Inc and Takeda Pharmaceuticals North America Inc announced the launch of Amitiza soft-gel capsules, which were approved by the FDA in January 2006. The capsules, which are indicated for the treatment of chronic idiopathic constipation in adults, are now available by prescription in pharmacies across the United States. Amitiza is the first selective chloride channel activator approved for therapeutic use in chronic idiopathic constipation, which affects both men and women and more often affects patients over the age of 65.

Dosage Form: Capsules: 24 mcg

For More Information: www.amitiza.com

Daytrana (methylphenidate transdermal system)

Marketed by: Shire Pharmaceuticals (Philadelphia, Pa)

Indication: April 6, 2006?The FDA approved Shire Pharmaceuticals' Daytrana, the first and only nonoral medication for the treatment of attention-deficit/hyperactivity disorder (ADHD). It offers a convenient option to deliver medication for patients with ADHD, in a once-daily transdermal patch formulation.

Dosage Form: Transdermal patch: 10, 15, 20, and 30 mg

For More Information: www.daytrana.com

EMSAM (selegiline transdermal system)

Marketed by: Bristol-Myers Squibb Co (Princeton, NJ) and Somerset Pharmaceuticals (Tampa, Fla), a joint venture between Mylan Laboratories Inc and Watson Pharmaceuticals Inc

Indication: February 28, 2006?The FDA granted approval for EMSAM, the first transdermal patch for the treatment of major depressive disorder (MDD) in adults. EMSAM, in a transdermal delivery system, is a monoamine oxidase inhibitor that has been shown to relieve depressive symptoms in patients with MDD.

Dosage Form: Transdermal patch: 6 mg/24 hr, 9 mg/24 hr, 12 mg/24 hr

For More Information: www.emsam.com

Loestrin 24 Fe (norethindrone acetate and ethinyl estradiol tablets)

Marketed by: Warner Chilcott (Rockaway, NJ)

Indication: February 20, 2006?Warner Chilcott announced that the FDA granted approval for its 24-day oral contraceptive, Loestrin 24 Fe, for the prevention of pregnancy. It is the first birth control pill approved in the United States to provide 24 days of active hormonal therapy and 4 days of iron-containing placebo pills.

Dosage Form: Tablets: blister card containing 24 white active tablets (each tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol) and 4 placebo tablets (each tablet contains 75 mg ferrous fumarate)

For More Information: www.loestrin24.com

MetroGel (metronidazole gel) 1%

Marketed by: Galderma Laboratories (Fort Worth, Tex)

Indication: April 14, 2006?Galderma Laboratories announced the launch of a new larger size of its MetroGel, indicated for the topical treatment of inflammatory lesions of rosacea. It has replaced MetroGel 0.75%. MetroGel 1% incorporates a higher concentration of metronidazole and a reduced dosage of once-daily versus twice-daily use. The new product is now available in a 60-g tube, enlarged from the previous 45-g tube, to provide a lower cost per gram and fewer refills.

Dosage Form: Gel: 60-g tube

For More Information: www.metrogel.com

Relenza (zanamivir for inhalation)

Marketed by: GlaxoSmithKline (Research Triangle Park, NC)

Indication: March 30, 2006?The FDA approved the use of Relenza for the prevention (prophylaxis) of influenza in adults and children 5 years of age and older. This antiviral medication was previously approved for the treatment of influenza A and B virus infections in adults and children.

Dosage Form: 10 mg once daily for 10 days: 2 inhalations (one 5-mg blister per inhalation)

For More Information: www.relenza.com

Tretin?X (tretinoin)

Marketed by: Triax Pharmaceuticals LLC (Cranford, NJ)

Indication: April 18, 2006?Triax Pharmaceuticals announced the launch of Tretin?X, supplied in both cream and gel and indicated for the topical treatment of acne vulgaris. It is a complete acne system designed to simplify treatment by providing the cleansing and moisturizing steps outlined for retinoid therapy.

Dosage Form: Gel: 35-g tubes, 0.025% and 0.01% Cream: 35-g tubes, 0.1%, 0.05%, and 0.025%

For More Information: www.triaxpharma.com

Truvada (emtricitabine and tenofovir disoproxil fumarate)

Marketed by: Gilead Sciences Inc (Foster City, Calif)

Indication: March 8, 2006?The FDA granted traditional approval status for Truvada, a fixed-dose product that combines Gilead's 2 antiretrovirals, Emtriva and Viread, in a single daily tablet. It is indicated in combination with other antiretroviral agents (such as nonnucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults.

Dosage Form: Tablet: 200 mg emtricitabine and 300 mg of tenofovir disoproxil fumarate

For More Information: www.truvada.com

YAZ (3 mg drospirenone/20 mcg ethinyl estradiol)

Marketed by: Berlex Inc (Wayne, NJ)

Indication: April 21, 2006?Berlex Inc announced the availability of YAZ, the first birth control pill to combine 20 mcg of ethinyl estradiol with the innovative progestin drospirenone in a 24-day active hormone pill regimen. With this oral contraceptive (OC), there is less hormonal fluctuation between cycles than with traditional OCs due to the 24-day active hormone pill regimen combined with the 30-hr half-life of drospirenone.

Dosage Form: Tablets: blister pack containing 24 active tablets (each containing 3 mg drospirenone and 0.02 mg ethinyl estradiol) and 4 inert tablets

For More Information: www.berlex.com

Nephrocaps Softgels

Marketed by: Fleming and Co Pharmaceuticals (St. Louis, Mo)

Indication: April 20, 2006?Nephrocaps Softgels, specially formulated to replace critical vitamins lost during dialysis and in some renal diseases, became available in 30-and 90-day unit-of-use bottles. The product is time-saving and convenient for pharmacists to label and dispense. Nephrocaps Softgels are easy to swallow and are rich in B-complex vitamins, folate (1 mg), and vitamin C.

Dosage Form: Softgel: 1 Nephrocaps Softgel daily

For More Information: www.flemingcompany.com