Pharmacy Times

Rx Product News


Uloric

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

Indication:
Takeda Pharmaceuticals North America Inc announced FDA approval of Uloric (febuxostat), the first new treatment option in more than 40 years for patients who have hyperuricemia associated with gout. Uloric, a xanthine oxidase inhibitor, lowers levels of serum uric acid in patients with hyperuricemia associated with gout, a condition that is estimated to affect >5 million patients in the United States. Uloric is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.

Dosage Form:
Tablets: 40 and 80 mg

For More Information:
www.uloric.com


Apriso

Marketed by:
Salix Pharmaceuticals Inc (Raleigh, NC)

Indication:
Salix Pharmaceuticals Inc announced FDA approval of Apriso (mesalamine) extended-release capsules. Apriso is a locally-acting aminosalicylate, as well as the first and only mesalamine product FDA approved for once-daily dosing, indicated for the maintenance of remission of ulcerative colitis (UC) in adults. The product also is the first and only 5-ASA with Intellicor extended-release delivery technology for 24-hour protection from flare-ups. Apriso has been shown to be effective in helping UC patients stay in remission for up to 6 months.

Dosage Form:
Extended-release capsules: 0.375 g

For More Information:
www.salix.com
800-508-0024



Astepro Nasal Spray

Marketed by:
MEDA Pharmaceuticals, Inc (Somerset, NJ)

Indication:
MEDA Pharmaceuticals has launched Astepro (azelastine hydrochloride) Nasal Spray for the management of seasonal allergic rhinitis symptoms. Indicated for patients 12 years and older, Astepro is formulated as a metereddose solution for intranasal administration, and contains sucralose, a noncaloric sweetener with proven safety in >100 scientific studies. It provides symptom relief in as little as 30 minutes, without the use of steroids or pseudoephedrine. Astepro offers increased tolerability for patients with seasonal allergic rhinitis´┐Ża condition that affects as many as 40 million people across the nation, according to MEDA.

Dosage Form:
Nasal spray: 137 mcg

For More Information:
www.astepro.com



Savella

Marketed by:
Forest Laboratories Inc (New York, NY) and Cypress Bioscience Inc (San Diego, CA)

Indication:
Forest Laboratories Inc and Cypress Bioscience Inc announced FDA approval of Savella (milnacipran HCI), a selective serotonin and norepinephrine reuptake inhibitor indicated for the management of fibromyalgia. The product is the first drug approved to treat the symptoms of fibromyalgia using a composite responder analysis. Savella is not approved for pediatric use. Savella should be prescribed with caution in patients with a history of a seizure disorder, mania, or controlled narrow-angle glaucoma.

Dosage Form:
Tablets: 12.5, 25, 50, and 100 mg

For More Information:
www.savella.com



Vectical Ointment

Marketed by:
Galderma Laboratories (Fort Worth, TX)

Indication:
The company announced FDA approval of Vectical (calcitriol) Ointment, a novel topical therapy for mild-tomoderate plaque psoriasis in adults. The product contains calcitriol, the naturally-occurring, active form of vitamin D3. Caution should be exercised with Vectical Ointment use in patients with known or suspected disturbances in calcium homeostasis, who are taking calcium or vitamin D supplements, or who are on medications known to increase serum calcium levels.

Dosage Form:
Each gram of Vectical Ointment contains 3 mcg/g of calcitriol

For More Information:
www.vectical.com



Seroquel XR

Marketed by:
AstraZeneca (Wilmington, DE)

Indication:
AstraZeneca announced the launch of Seroquel XR (quetiapine fumarate) for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar l disorder, and the maintenance treatment of bipolar l disorder as adjunctive therapy to lithium or divalproex. Seroquel XR is the only drug FDA approved for the treatment of acute depressive, manic, and mixed episodes of bipolar disorder.

Dosage Form:
Tablets: 50, 150, 200, 300, and 400 mg

For More Information:
www.seroquelxr.com



Gelnique Gel

Marketed by:
Watson Pharmaceuticals Inc (Corona, CA)

Indication:
Watson Pharmaceuticals Inc announced FDA approval of Gelnique (oxybutynin chloride) Gel 10%. It is the first and only topical gel for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency. Gelnique Gel will provide OAB patients a novel alternative to the available oral treatments. Because the active ingredient in Gelnique Gel is delivered transdermally, it is not metabolized by the liver in the same way as orally administered oxybutynin. The gel is clear and quick-drying, and should be applied once daily to the thigh, abdomen, upper arm, or shoulder for a consistent dose of oxybutynin over a 24-hour period.

Dosage Form:
Each 1-g unit dose contains 100 mg/g oxybutynin chloride gel

For More Information:
www.gelnique.com



Coartem Dispersible

Marketed by:
Novartis AG (Basel, Switzerland

Indication:
Novartis announced the launch of a new pediatric formulation Coartem (artemether/lumefantrine) Dispersible for the treatment of uncomplicated malaria in infants and children. The sweet-tasting Coartem Dispersible contains the same amount of artemether and lumefantrine as Coartem, and is the first dispersible fixed-dose artemisinin-based combination therapy developed especially for children. The company will provide Coartem Dispersible without profit for public sector use in malaria-endemic regions.

Dosage Form:
Tablets: 20 and 120 mg

For More Information:
www.novartis.com