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Trilipix

Marketed by:
Abbott Laboratories (Abbott Park, IL)

Indication:
December 15, 2008—The FDA approved Abbott's Trilipix (fenofibric acid) delayed-release capsules for use along with diet to help lower triglycerides and low-density lipoprotein cholesterol, and to raise high-density lipoprotein cholesterol in patients with lipid problems. It is a peroxisome proliferator receptor alpha and is the first and only fibrate to be approved for use in combination with a statin. Trilipix has not been shown to prevent heart disease or heart attack.

Dosage Form:
Capsules: 45 and 135 mg

For More Information:
www.trilipix.com
800-633-9110


Epiduo Gel

Marketed by:
Galderma Laboratories LP (Fort Worth, TX)

Indication:
January 6, 2009—Galderma Laboratories announced the availability of Epiduo (adapalene and benzoyl peroxide) Gel 0.1%/2.5%. This product represents the first and only, once-daily, topical acne treatment that combines the well-tolerated retinoid adapalene and benzoyl peroxide, an antimicrobial with no evidence of promoting bacterial resistance. Epiduo Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Patients should apply the gel in a thin film to affected areas of the face and/or trunk once daily after washing; patients should use a peasized amount for each area of the face (eg, forehead, chin, each cheek). The eyes, lips, and mucous membranes should be avoided during application.

Dosage Form:
Each gram of Epiduo Gel contains 1 mg (0.1%) adapalene and 25 mg (2.5%) benzoyl peroxide in an aqueous-based gel.

For More Information:
www.galdermaUSA.com



Latisse

Marketed by:
Allergan Inc (Irvine, CA)

Indication:
December 26, 2008—Allergan Inc announced FDA approval of Latisse (bimatoprost ophthalmic solution) 0.03% as a novel treatment for hypotrichosis of the eyelashes (having inadequate or not enough eyelashes). Latisse is the first and only science-based treatment approved by the FDA to enhance eyelash prominence as measured by increases in length, thickness, and darkness of eyelashes. Bimatoprost, the active pharmaceutical ingredient in Latisse, is a structural prostaglandin analog—a lipid compound derived from fatty acids designed to bind to prostaglandin receptors. The solution is intended for use on the skin of the upper eyelid margins at the base of the eyelashes (not the lower eyelid).

Dosage Form:
Bimatoprost ophthalmic solution 0.3 mg/mL

For More Information:
www.latisse.com



Norditropin

Marketed by:
Novo Nordisk Inc (Princeton, NJ)

Indication:
November 4, 2008—The FDA approved an additional indication for Norditropin (somatropin [rDNA origin] injection) for the treatment of short stature in children born small for gestational age with no catch-up growth by 2 to 4 years of age. Children born with this condition now have a new treatment option to help them grow to a normal height. It also is indicated for the treatment of children with short stature associated with Noonan syndrome, treatment of children with short stature associated with Turner syndrome, and treatment of children with growth failure due to inadequate secretion of endogenous growth hormone. Norditropin also is indicated for replacement of endogenous growth hormone in adults with either adult- or childhood-onset growth hormone deficiency.

Dosage Form:
Cartridges are available for use with the corresponding NordiPens or preloaded in the Norditropin NordiFlex pens—5 mg/1.5 mL: cartridge and Norditropin NordiFlex pen; 10 mg/1.5 mL: Norditropin NordiFlex pen only; 15 mg/1.5 mL: cartridge and Norditropin NordiFlex pen.

For More Information:
www.novonordisk-us.com



Moxatag

Marketed by:
MiddleBrook Pharmaceuticals Inc (Westlake, TX)

Indication:
January 7, 2009—MiddleBrook Pharmaceuticals Inc announced that the launch of Moxatag (amoxicillin extended-release) Tablets, 775 mg, will begin in March. Moxatag is the first and only once-a-day amoxicillin product indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients aged 12 years or older. The formulation of Moxatag consists of 1 immediate-release and 2 delayed-release components of amoxicillin. These 3 components are combined in a specific ratio to prolong the release of amoxicillin from Moxatag, compared with currently available immediate-release amoxicillins.

Dosage Form:
Tablets: 775 mg

For More Information:
www.middlebrookpharma.com



PreNexa

Marketed by:
Upsher-Smith Laboratories Inc (Minneapolis, MN)

Indication:
December 3, 2008—Upsher-Smith Laboratories announced its plans to market PreNexa, the first and only single-gel capsule prenatal vitamin with the most plant-based docosahexanoic acid (DHA, 265 mg) for women considering pregnancy, pregnant women, and mothers who are breastfeeding. PreNexa is a once-daily single-gel capsule indicated to provide vitamin/mineral and plant-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and nonlactating mothers, and throughout the childbearing years.

Dosage Form:
One soft gel capsule daily or as directed by a physician

For More Information:
www.prenexa.com



Prezista

Marketed by:
Tibotec Therapeutics/Division of Ortho Biotech Products, LP (Bridgewater, NJ)

Indication:
November 19, 2008—Tibotec Therapeutics announced the launch of a 400-mg Prezista (darunavir) tablet. Prezista is a protease inhibitor indicated for the treatment of HIV infection in adult patients. Prezista also is indicated for the treatment of HIV infection in pediatric patients 6 years of age and older. The product must be coadministered with ritonavir and with other antiretroviral agents. In addition, the FDA recently granted approval for an expanded indication for Prezista once-daily dosing as part of an HIV combination therapy in treatment-na?ve adults.

Dosage Form:
Tablets: 75, 300, 400, and 600 mg

For More Information:
www.prezista.com
877-REACH-TT (877-732-2488)



Zolpimist

Marketed by:
NovaDel Pharma Inc (Flemington, NJ)

Indication:
December 22, 2008—NovaDel Pharma Inc announced that Zolpimist (zolpidem tartrate) 5 mg and 10 mg Oral Spray was approved by the FDA for the shortterm treatment of insomnia characterized by difficulties with sleep initiation. Zolpimist contains zolpidem tartrate, the same active ingredient as Ambien. Due to its rapid onset of action, patients should take Zolpimist immediately before bedtime and be prepared to get a full night's sleep (7-8 hours).

Dosage Form:
Oral spray: 5 and 10 mg

For More Information:
www.novadel.com


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