/publications/issue/2010/May2010/RxProductNews-0510

Rx Product News

Author:

HOT Rx


Fanapt

Marketed by:
Novartis (East Hanover, NJ)

Indication:
Novartis announced that Fanapt (iloperidone) tablets are now available for use across the United States for the acute treatment of schizophrenia in adults. Fanapt is a twice-daily, oral atypical antipsychotic approved by the FDA on May 6, 2009. In choosing among treatments, prescribers should consider the ability of Fanapt to prolong the QT interval and the use of other drugs first. Prescribers should also consider the need to titrate Fanapt slowly to avoid orthostatic hypotension, which may lead to delayed effectiveness compared with drugs that do not require similar titration. Novartis Pharma AG and Vanda Pharmaceuticals entered into an agreement in October 2009, pursuant to which Novartis has exclusive US and Canadian commercialization rights to Fanapt.

Dosage Form:
Tablets: 1, 2, 4, 6, 8, 10, and 12 mg

For More Information:
www.fanapt.com


Dacogen

Marketed by:
Eisai Inc (Woodcliff Lake, NJ)

Indication:
Eisai Inc recently announced the FDA approval of a 5-day dosing regimen for Dacogen (decitabine) for Injection to treat patients with myelodysplastic syndromes, a group of bone marrow diseases that alter the production of functional blood cells. The new outpatient dosing option—which will be administered at a dose of 20-mg/m2 continuous intravenous (IV) infusion over 1 hour, repeated daily for 5 days per cycle (the cycle is repeated every 4 weeks)— provides the flexibility of a dosing regimen with a reduced infusion time. The already approved Dacogen 3-day regimen is administered in an inpatient setting at a dose of 15-mg/m2 continuous IV infusion over 3 hours repeated every 8 hours for 3 days per cycle, and repeated every 6 weeks.

Dosage Form:
Lyophilized powder in a single-dose vial, 50 mg/vial

For More Information:
www.eisai.com


Dexilant

Marketed by:
Takeda Pharmaceuticals North America Inc (Deerfield, IL)

Indication:
Takeda Pharmaceuticals North America Inc announced that KAPIDEX (dexlansoprazole) will now be marketed under the new product trade name DEXILANT (dexlansoprazole). The product is indicated for heartburn associated with symptomatic nonerosive gastroesophageal reflux disease, the healing of erosive esophagitis (EE), and the maintenance of healed EE. This name change was due to reports of dispensing errors between KAPIDEX and Casodex (bicalutamide) and Kadian (morphine sulfate extended-release). Takeda, in coordination with the FDA, decided that a name change would be the best way to ensure patient safety and minimize future errors. The formulation, indication, and approved dosages of DEXILANT will remain the same as KAPIDEX. Markings on the capsules will not change. DEXILANT will have a new National Drug Code number and is now available in US pharmacies.

Dosage Form:
Delayed-release capsules: 30 and 60 mg

For More Information:
www.dexilant.com
877-TAKEDA-7 (877-825-3327)


Lamictal XR

Marketed by:
GlaxoSmithKline (Research Triangle Park, NC)

Indication:
GlaxoSmithKline announced that the FDA approved Lamictal XR (lamotrigine) Extended-Release Tablets as once-a-day, add-on therapy for epilepsy in patients ages 13 years and older with primary generalized tonic-clonic seizures. Lamictal XR is already approved for partial-onset seizures (with or without secondary generalization) for patients in this age group. Primary generalized tonic-clonic seizures, known formerly as “grand mal” seizures, are considered the most common form of generalized (affecting both sides of the brain) seizure, occurring in approximately 20% of patients with epilepsy.

Dosage Form:
Extended-release tablets: 25, 50, 100, and 200 mg

For More Information:
www.gsk.com
www.lamictalxr.com


Norvir

Marketed by:
Abbott Laboratories (Abbott Park, IL)

Indication:
Abbott announced that the FDA granted approval of a new tablet formulation of the company’s antiretroviral medication Norvir (ritonavir), which is used in combination with other antiretroviral medications to treat HIV. The new Norvir tablets can be stored at room temperature and do not require refrigeration, making them more convenient for patients. While the rate of drug absorption is different, there is no requirement for dosage change. The Norvir tablet was developed using Abbott’s Meltrex technology, a proprietary melt-extrusion process, making it more heat-stable. This technology makes it easier for patients with HIV to travel with and store their medication.

Dosage Form:
Tablets: 100 mg Soft-gelatin capsules: 100 mg

For More Information:
www.abbott.com


Oforta


Marketed by:
sanofi-aventis (Bridgewater, NJ)

Indication:
Oforta (fludarabine phosphate), for the treatment of B-cell chronic lymphocytic leukemia (CLL), is now available. Oforta is a nucleotide metabolic inhibitor indicated as a single agent for the treatment of adult patients with B-cell CLL whose disease has not responded to or has progressed during or after treatment with at least 1 standard alkylating-agent–containing regimen. Oforta is the first oral fludarabine approved in the United States for adult patients whose disease has not responded to, or has progressed during or after standard treatment.

Dosage Form:
Tablets: 10 mg

For More Information:
www.sanofi-aventis.us


Qutenza


Marketed by:
NeurogesX Inc (San Mateo, CA)

Indication:
NeurogesX Inc recently announced the availability of Qutenza (capsaicin) 8% patch, the first and only product containing prescription-strength capsaicin. The results of clinical studies have shown that a single 1-hour Qutenza application can provide 3 months’ relief from pain associated with postherpetic neuralgia (PHN), the nerve pain that can occur after shingles. Qutenza, a TRPV1 channel agonist, is the first prescription-strength topical treatment for PHN to be approved by the FDA in more than 10 years. Qutenza can be used alone or with other pain medications.

Dosage Form:
Qutenza patch contains 8% capsaicin (640 mcg/cm2). Each patch contains a total of 179 mg of capsaicin. For

More Information:
www.Qutenza.com


Xiaflex


Marketed by:
Auxilium Pharmaceuticals Inc (Malvern, PA)

Indication:
Auxilium Pharmaceuticals Inc recently announced that XIAFLEX (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated biologic, is now available by prescription in the United States for the treatment of adult Dupuytren’s contracture patients with a palpable cord. XIAFLEX has a distinct mechanism of action. When injected directly into a Dupuytren’s cord, it enzymatically disrupts collagen. As a result of collagen disruption, contracture may be reduced and range of motion may be improved.

Dosage Form:
Single-use vials containing 0.9 mg of collagenase clostridium histolyticum as a sterile, lyophilized powder for reconstitution. Sterile diluents for reconstitution are also provided in a single-use glass vial.

For More Information:
www.xiaflex.com