/publications/issue/2010/April2010/RxProductNews-0410

Rx Product News

Author:

HOT Rx


Norditropin FlexPro

Marketed by:

Novo Nordisk (Princeton, NJ)

Indication:

The FDA recently approved Norditropin FlexPro (somatropin [rDNA origin] injection)—a prefilled injection pen to be used by children and adults with growth hormone disorders. Norditropin FlexPro has a user-friendly design, and the user will hear a click when the medication has left the pen. The product requires no reconstitution and no loading of cartridges. After the first use, the 5-mg/1.5-mL and 10-mg/1.5-mL pens may be left at room temperature for up to 3 hours without spoilage.

Dosage Form:
5-mg/1.5-mL, 10-mg/1.5-mL, and 15-mg/1.5-mL pens

For More Information:
www.norditropin-us.com


Intuniv

Marketed by:
Shire plc (Philadelphia, PA)

Indication:
Shire plc recently announced the availability of Intuniv (guanfacine) extended-release tablets in pharmacies across the United States for the treatment of attention-deficit/ hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17. Intuniv is a oncedaily formulation of guanfacine and is the first and only nonscheduled alpha-2A receptor agonist approved for the treatment of ADHD. Dosing should begin at 1 mg once daily and should be adjusted in increments of no more than 1 mg/week.

Dosage Form:

Tablets: 1, 2, 3, and 4 mg

For More Information:
www.intuniv.com


EXALGO

Marketed by:
Covidien (St. Louis, MO)

Indication:
Covidien recently announced that the FDA approved the new drug application for EXALGO (hydromorphone HCl) extended-release tablets. EXALGO is indicated for oncedaily administration for the management of moderate-tosevere pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period. EXALGO uses OROS Push-Pull osmotic delivery system designed to release the opioid at a controlled rate—with this, the drug is formulated to help minimize the peaks and troughs that are sometimes experienced by chronic pain patients. Exalgo contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics.

Dosage Form:

Tablets: 8, 12, and 16 mg

For More Information:
www.covidien.com


Benicar

Marketed by:
Daiichi Sankyo Inc (Parsippany, NJ)

Indication:
Daiichi Sankyo Inc announced recently that the FDA approved the hypertension treatment Benicar (olmesartan medoxomil) for use in children and adolescents 6 to 16 years of age. Benicar was originally approved in 2002 for the treatment of hypertension in adults. With this new approval, a new treatment option exists for the rapidly growing population of children (approximately 5% of, or 3.6 million, US children) suffering from high blood pressure. Studies have found that the rate of high blood pressure in children is on the rise, coinciding with children’s increase in weight.

Dosage Form:

Tablets: 5, 20, and 40 mg

For More Information:
www.dsi.com
www.benicar.com


Iprivask

Marketed by:
Canyon Pharmaceuticals (Hunt Valley, MD)

Indication:

The FDA recently approved a new deep vein thrombosis (DVT) prophylaxis agent. Canyon Pharmaceuticals announced the availability of Iprivask (desirudin for injection), the first direct thrombin inhibitor approved in the United States by the FDA for the prevention of DVT, which may lead to pulmonary embolism in patients undergoing elective hip replacement surgery.

Dosage Form:

Iprivask 15 mg is supplied as a single-dose (15.75 mg) lyophilized powder with an accompanying sterile, nonpyrogenic diluent (0.6 mL of mannitol USP [3%] in water for injection). Each Iprivask vial contains 15.75 mg desirudin and the following inactive ingredients: 1.31 mg anhydrous magnesium chloride USP, sodium hydroxide for injection USP.

For More Information:
www.canyonpharma.com


Mirapex ER

Marketed by:
Boehringer Ingelheim Pharmaceuticals Inc (Ridgefield, CT)

Indication:
Boehringer Ingelheim Pharmaceuticals recently announced that the FDA approved Mirapex ER (pramipexole dihydrochloride) extended-release tablets. Mirapex ER, a nonergot dopamine agonist, is a new oncedaily treatment option for the signs and symptoms of early idiopathic Parkinson’s disease; however, it is not indicated for advanced Parkinson’s disease. Parkinson’s disease is a progressive neurologic disorder that affects almost 1 million individuals in the United States. Mirapex is still available in a 3-times-daily immediate- release formulation.

Dosage Form:
Tablets: 0.375, 0.75, 1.5, 3, and 4.5 mg

For More Information:
http://us.boehringer-ingelheim.com
800-542-6257


Cayston

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

Indication:
Gilead Sciences Inc announced that the FDA granted marketing approval for Cayston (aztreonam for inhalation solution) as a treatment to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa. The safety and effectiveness of Cayston have not been established in pediatric patients younger than age 7, patients with forced expiratory volume in 1 second of <25% or >75% predicted, or patients colonized with Burkholderia cepacia. Cayston is administered at a dose of 75 mg 3 times daily over a 28-day period and is delivered via the Altera Nebulizer System.

Dosage Form:
• Lyophilized aztreonam (75 mg/vial)
• Diluent (0.17% sodium chloride): 1 mL/ampule

For More Information:
www.cayston.com
877-7CAYSTON (877-722-9786)


Urocit-K 15 mEq

Marketed by:
Mission Pharmacal Co (San Antonio, TX)

Indication:
Mission Pharmacal Co announced the introduction of the Urocit-K 15-mEq (potassium citrate) extended-release tablet. The new formulation builds on the heritage of Urocit-K with a maximum-strength alkalinizing agent to help prevent kidney stone recurrence in more than 90% of patients. Urocit-K is a slow-release formulation of potassium citrate for treatment of kidney stones (nephrolithiasis) in patients with renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate stones of any etiology and uric acid lithiasis, with and without uric acid stones. The product corrects the pH of the urine and elevates a naturally occurring urinary inhibitor of calcium stone formation (citrate) and lowers saturation of calcium oxalate.

Dosage Form:
Tablets: 5, 10, and 15 mEq

For More Information:
www.urocit-k.com