Rx Product News

Published Online: Wednesday, October 1, 2008

Asmanex

Marketed by:
Schering-Plough Corp (Kenilworth, NJ)

Indication:
August 19, 2008?Schering-Plough Corp announced that Asmanex Twisthaler 110 mcg (mometasone furoate inhalation powder) is available in pharmacies nationwide. Asmanex is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older and is the first and only once-daily inhaled corticosteroid inhaler approved for this use in children as young as 4. In February 2008, Asmanex was approved for children aged 4 to 11 by the FDA. It is not indicated for the relief of sudden asthma symptoms or in children less than 4 years of age.

Dosage Form:
110 mcg (for children between 4 and 11 years old) and 220 mcg (for patients aged 12 and older)

For More Information:
www.schering-plough.com;
www.spfiles.com/piasmanex.pdf



Kerol ZX and Kerol Emulsion M

Marketed by:
PharmaDerm, a division of Nycomed US (Florham Park, NJ)

Indication:
August 29, 2008?PharmaDerm announced the launch of Kerol ZX and Kerol Emulsion to the dermatology and podiatry markets. These specialty products have been developed for improved treatment of dry skin and damaged nails. They are indicated for debridement and promotion of normal healing of hyperkeratotic surface lesions and contain a zinc undecylate and lactic acid vehicle. These products work by gently dissolving the intercellular matrix, resulting in the loosening of the horny outer layer of skin and revealing healthy skin. They are indicated for hyperkeratotic conditions, such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, and damaged and devitalized nails.

Dosage Form
: Kerol Emulsion: 10-oz tube for application to larger skin surface areas Kerol ZX: 12-mL prefilled applicator to deliver relief to smaller areas, such as nails, corns, and calluses

For More Information:
www.pharmaderm.com



Nplate

Marketed by:
Amgen Inc (Thousand Oaks, CA)

Indication:
August 22, 2008?Amgen Inc announced that the FDA approved Nplate (romiplostim), the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen-removed) and nonsplenectomized adults with chronic immune thrombocytopenic purpura (ITP). ITP is a serious autoimmune disorder characterized by low platelet counts in the blood, which can lead to serious bleeding events. Nplate, the first FDA-approved peptibody protein, works by raising and sustaining platelet counts representing a novel approach for the long-term treatment of this chronic disease.

Dosage Form:
250 or 500 mcg of deliverable romiplostim in single-use vials

For More Information:
877-NPLATE1 (877-675-2831)
www.nplate.com



Omnitrope Pen 10

Marketed by:
Sandoz Inc (Princeton, NJ)

Indication:
September 3, 2008?Sandoz received approval from the FDA for its Omnitrope Pen 10 with liquid cartridge. Omnitrope, a somatropin, is approved for long-term treatment of pediatric patients who have growth failure and long-term replacement therapy in adults with growth hormone deficiency. The Omnitrope Pen 10 with liquid cartridge provides increased treatment flexibility for physicians and a more convenient dosage form for patients. Omnitrope is highly similar to the reference product, Genotropin, in its safety and efficacy profiles.

Dosage Form:
5 mg (Omnitrope Pen 5) and 10 mg

For More Information:
www.us.sandoz.com



OneTouch Ping

Marketed by:
Animas Corp, part of the Johnson & Johnson family of companies (West Chester, PA)

Indication:
July 1, 2008?Animas Corp announced the clearance of its OneTouch Ping Glucose Management System by the FDA. OneTouch Ping is the first full-feature insulin pump that wirelessly communicates with a blood glucose meter-remote. Using the OneTouch Ping meter-remote, an individual can calculate insulin doses and opt to wirelessly instruct the pump to deliver them without touching the pump at all, giving patients more freedom and flexibility. OneTouch Ping can be clipped to a belt, tucked in a pocket, or secured under clothing. The meter-remote also uses OneTouch Ultra Test Strips.

Dosage Form:
OneTouch Ping delivers the lowest basal increments (0.025 U/hr) and lowest bolus increments (0.05 U) available for more precise basal dosing

For More Information:
877-937-7867
www.animascorp.com



Vyvanse

Marketed by:
Shire Limited (Basingstoke, UK, and Philadelphia, PA)

Indication:
August 26, 2008?Shire Limited announced the availability of Vyvanse in 3 additional dosage strengths in US pharmacies nationwide. This brings the total number of Vyvanse dosage strengths to 6: 20, 30, 40, 50, 60, and 70 mg. The expanded Vyvanse dosing options will allow physicians to individualize treatment for each patient. Vyvanse also recently received approval to treat attention-deficit/ hyperactivity disorder (ADHD) in adults; it received approval in 2007 for the treatment of ADHD in children. Vyvanse is the first prodrug stimulant to treat ADHD and was shown to provide consistent delivery of active medication from patient to patient.

Dosage Form:
Capsules: 20, 30, 40, 50, 60, and 70 mg

For More Information:
www.vyvanse.com


Hot OTC

Durezol

Marketed by:
Sirion Therapeutics (Tampa, FL)

Indication:
June 24, 2008?Sirion Therapeutics announced that the FDA approved its New Drug Application for Durezol (difluprednate ophthalmic emulsion) 0.05%, a topical corticosteroid indicated for the treatment of inflammation and pain associated with ocular surgery. Durezol is a difluorinated derivative of prednisolone and has potent anti-inflammatory activity. Instructions for administration are as follows: instill 1 drop into the conjunctival sac of the affected eye(s) 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response.

Dosage Form:
Durezol contains 0.05% difluprednate as a sterile preserved ophthalmic emulsion for topical ophthalmic use only

For More Information: www.siriontherapeutics.com


Soma 250 mg

Marketed by:
Meda Pharmaceuticals Inc (Somerset, NJ)

Indication:
September 2008?Soma (carisoprodol) 250 mg, NDC #0037-2250-10, is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions, such as backache. Meda offers a $30 instant savings coupon. There is no generic substitute for Soma 250 mg.

Dosage Form:
One 250-mg tablet 3 times daily and at bedtime for up to 3 weeks

For More Information:
www.soma250.com



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