/publications/issue/2009/December2009/RxProductNews-1209

Rx Product News

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HOT Rx


Stelara


Marketed by:
Centocor Ortho Biotech Inc (Horsham, PA)

Indication:
Centocor Ortho Biotech recently announced that the FDA approved Stelara (ustekinumab) for the treatment of adult patients 18 years or older with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Stelara is a first-in-class human monoclonal antibody that selectively targets the cytokines interleukin- 12 (IL-12) and IL-23, naturally occurring proteins that are believed to play a role in the development of psoriasis. Psoriasis is an inflammatory disorder characterized by red, scaly patches of skin that can cause physical pain. Stelara requires as few as 4 injections every 12 weeks following 2 initial loading doses.

Dosage Form:
45 mg/0.5 mL in a single-use glass vial; 90 mg/1 mL in a single-use glass vial

For More Information:
www.STELARAinfo.com



Byetta

Marketed by:
Amylin Pharmaceuticals Inc (San Diego, CA) and Eli Lilly and Co (Indianapolis, IN)

Indication:
The FDA recently approved an additional indication for Byetta (exenatide) injection—it is now indicated for use as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Previously, it was approved for use only in patients also taking other diabetes medications and had not achieved adequate glycemic control. Byetta is the first and only GLP-1 receptor antagonist approved by the FDA for the treatment of type 2 diabetes. The medication is not insulin and should not be taken instead of insulin, and it is not for patients with type 1 diabetes or diabetic ketoacidosis.

Dosage Form:
250 mcg/mL exenatide in: 5 mcg per dose, 60 doses, 1.2-mL prefilled pen; and 10 mcg per dose, 60 doses, 2.4-mL prefilled pen

For More Information:
www.byetta.com



Acuvail

Marketed by:
Allergan Inc (Irvine, CA)

Indication:
Allergan Inc recently announced the FDA approval of Acuvail (ketorolac tromethamine ophthalmic solution) 0.45%. Acuvail is an advanced, preservative-free formulation of ketorolac, a nonsteroidal anti-inflammtory drug, indicated for the treatment of pain and inflammation following cataract surgery. One drop of Acuvail should be applied to the affected eye twice daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 2 weeks of the postoperative period.

Dosage Form:
4.5-mg/mL ketorolac tromethamine solution in a singleuse vial

For More Information:
www.allergan.com



Cervarix

Marketed by:
GlaxoSmithKline (London, UK)

Indication:
GlaxoSmithKline announced that the FDA approved Cervarix (human papillomavirus [HPV] bivalent [types 16 and 18] vaccine, recombinant) for the prevention of cervical precancers and cervical cancer associated with oncogenic HPV types 16 and 18 for use in girls and young women (aged 10-25). Cervarix does not prevent disease caused by all HPV types. Approximately 100 types of HPV have been identified and, of these, approximately 15 virus types are known to cause cervical cancer. Cervarix is administered in a 3-dose schedule (at 0, 1, and 6 months) that should be completed within 6 months of the initial dose. In clinical trials, Cervarix was shown to be 93% efficacious in the prevention of cervical precancers associated with HPV 16 or 18, in women without evidence of current infection with, or prior exposure to, the same HPV type at the time of vaccination.

Dosage Form:
0.5-mL suspension for injection as a single-dose vial or prefilled syringe

For More Information:
www.gsk.com



Focalin XR

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

Indication:
The FDA approved a higher dose (30 mg) of Focalin XR (dexmethylphenidate HCl) extended-release capsules for the treatment of attentiondeficit/ hyperactivity disorder (ADHD). The new strength provides health care professionals with an additional treatment option that offers statistically significant improvement in ADHD symptoms for up to 12 hours, compared with placebo. Focalin XR is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome.

Dosage Form:
Extended-release capsules: 5, 10, 15, 20, and 30 mg

For More Information:
www.FocalinXR.com
888-NOW-NOVA



Saphris

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

Indication:
The FDA recently approved Saphris (asenapine) sublingual tablets for acute treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults. Saphris can be used as a first-line treatment and is the first psychotropic drug to receive initial approval for both of these indications simultaneously. Saphris sublingual tablets should be placed under the tongue and left to dissolve completely; they should not be swallowed. The tablets will dissolve within seconds.

Dosage Form:
Sublingual tablets: 5 and 10 mg

For More Information:
www.saphris.com



Gardasil

Marketed by:
Merck & Co Inc (Whitehouse Station, NJ)

Indication:

Merck & Co Inc announced that the FDA approved Gardasil (Human Papillomavirus [HPV] Quadrivalent [types 6, 11, 16, and 18] Vaccine, Recombinant) for use in boys and men 9 through 26 years of age for the prevention of genital warts caused by HPV types 6 and 11. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted for permissive use of the vaccine, which means that Gardasil may be given to men aged 9 through 26 to reduce the likelihood of acquiring genital warts at the discretion of the patient’s health care provider. Gardasil also is indicated in girls and women 9 through 26 years of age for the prevention of several diseases caused by HPV types included in the vaccine.

Dosage Form:
0.5-mL suspension for intramuscular injection at the following schedule: 0, 2, and 6 months

For More Information:
www.merck.com



Renvela

Marketed by:
Genzyme Corp (Cambridge, MA)

Indication:
Genzyme announced the US launch of Renvela (sevelamer carbonate) for oral suspension, a powder dosing option for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Renvela is the only phosphate binder available in both tablet and powder dosing options. Renvela powder will be available in a 2.4-g packet, which is equivalent to 3 Renvela 800-mg tablets, and should be given 3 times daily with meals. Each 2.4-g packet should be mixed with at least 2 oz of water. Based on clinical studies, the average prescribed daily dose of Renvela powder is approximately 7.2 g per day.

Dosage Form:
Tablets: 800 mg Powder: 0.8- and 2.4-g packet

For More Information:
www.renvela.com ■