Rx Product News

Published Online: Thursday, November 18, 2010
HOT Rx


ARICEPT 23 MG

Marketed by:

Eisai Inc (Woodcliff Lake, NJ) and Pfizer Inc (New York, NY)

Indication:
Eisai Inc and Pfizer Inc announced the FDA approval of a new once-daily, higher-dose Aricept (donepezil hydrochloride) 23-mg tablet for the treatment of moderate- to-severe Alzheimer’s disease (AD). Aricept 23-mg tablet offers another dosing option for patients with moderate-to-severe AD. Patients with moderate-to-severe AD who are established on a regimen of Aricept 10 mg for at least 3 months are candidates for dose escalation to Aricept 23 mg. Aricept is the first and only prescription medication approved by the FDA for the treatment of all stages of AD.

Dosage Form:
Tablets: 5, 10, and 23 mg; Orally disintegrating tablets: 5 and 10 mg

For More Information:
www.aricept.com/23mg/Aricept23landing.html




GARAMYCIN OPHTHALMIC OINTMENT USP

Marketed by:

Fera Pharmaceuticals, LLC (New York, NY)

Indication:
Fera Pharmaceuticals announced the launch of a preservative- free formulation of Garamycin (gentamicin sulfate) Ophthalmic Ointment USP. Garamycin is an antibiotic indicated for the topical treatment of ocular bacterial infections, including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryosystitis caused by susceptible strains of Staphylococcus aureus, Staphylococcus epidermis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcesens.

Dosage Form:
Ophthalmic ointment: 3.5-g sterile, tamperproof tube

For More Information:
www.ferapharma.com



H.P. ACTHAR GEL

Marketed by:

Questcor Pharmaceuticals, Inc (Anaheim, CA)

Indication:
The FDA approved Questcor’s supplemental new drug application for H.P. Acthar Gel (repository corticotropin injection) as monotherapy for the treatment of infantile spasms (IS), an extremely rare and potentially life-threatening form of epilepsy, in infants and children younger than 2 years of age. The product was previously indicated for the treatment of exacerbations of multiple sclerosis in adults and for the treatment of rheumatic disorders; collagen, dermatologic, ophthalmic, and respiratory diseases; and allergic and edematous states. In the treatment of IS, the recommended dose is 150 U/m2 divided into twice-≥daily intramuscular injections of 75 U/m2. After 2 weeks of treatment, dosing should be gradually tapered and discontinued over a 2-week period.

Dosage Form:
5-mL multidose vial containing 80 USP units per mL

For More Information:
www.acthar.com


ZUPLENZ

Marketed by:

Strativa Pharmaceuticals (Woodcliff Lake, NJ)

Indication:
The FDA approved Zuplenz (ondansetron) oral soluble film for the prevention of nausea and vomiting associated with radiotherapy and highly emetogenic and moderately emetogenic cancer chemotherapy, as well as the prevention of postoperative nausea and/or vomiting. The product rapidly dissolves on the tongue without the need for water. Ondansetron is a selective 5-HT3 receptor antagonist. Although its mechanism of action is not fully known, it is not a dopamine-receptor antagonist. Zuplenz is the first oral soluble film approved by the FDA as a prescription medication.

Dosage Form:
Oral soluble film: 4 and 8 mg

For More Information:
www.zuplenz.com



PRADAXA

Marketed by:

Boehringer Ingelheim Pharmaceuticals Inc (Ridgefield, CT)

Indication:
The FDA approved Pradaxa (dabigatran etexilate mesylate), a novel oral direct thrombin inhibitor, to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Pradaxa is an anticoagulant that inhibits thrombin, the central enzyme in the blood responsible for clot formation. Pradaxa was approved with a Medication Guide, informing patients of the risks of serious bleeding, that will be distributed each time a patient fills a new prescription. The recommended dosages for patients with a creatinine clearance greater than 30 mL/min is 150 mg orally twice daily, whereas patients with a creatinine clearance between 15 and 30 mL should take 75 mg orally twice daily.

Dosage Form:
Capsules: 75 and 150 mg

For More Information:
www.pradaxa.com
800-542-6257


BARACLUDE

Marketed by:

Bristol-Myers Squibb Company (Princeton, NJ)

Indication:
Bristol-Myers Squibb announced that the FDA approved the supplemental new drug application of Baraclude (entecavir) for the treatment of chronic hepatitis B (CHB) in adult patients with decompensated liver disease. Baraclude is indicated for the treatment of CHB infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease. In adults with decompensated liver disease, the dosage is 1 mg once daily. Baraclude should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).

Dosage Form:
Tablets: 0.5 and 1 mg; Oral solution: 0.05 mg/mL

For More Information:
www.baraclude.com


VERSAPRO CREAM BASE

Marketed by:

MEDISCA (Plattsburgh, NY)

Indication:
VersaPro Cream Base is an odorless, highly penetrating transdermal delivery vehicle that has stability from pH 2 to 12. VersaPro Cream Base has excellent drug compatibility with a wide range of active ingredients, making it suitable for the preparation of various pharmaceutical formulations in areas such as hormone replacement, pain management, and diabetic neuropathy. The unique water-in-oil emulsion formula is highly moisturizing, nongreasy, nonirritating, and paraben-free.

How Supplied:
100- and 500-g, and 2.5- and 5-kg containers

For More Information:
www.medisca.com
800-932-1039


LATUDA

Marketed by:

unovion Pharmaceuticals Inc (Marlborough, MA)

Indication:
The FDA has approved LATUDA (lurasidone HCl) tablets for the treatment of patients with schizophrenia. LATUDA is an oral, once-daily atypical antipsychotic agent that offers a first-line treatment option for patients with schizophrenia. The recommended starting dose is 40 mg once daily. LATUDA should be taken with food. Initial dose titration is not required, and the maximum recommended dose is 80 mg daily. LATUDA’s full prescribing information contains a boxed warning about the risk of increased mortality in elderly patients with dementia-related psychosis. LATUDA is available in pharmacies now.

Dosage Form:
Tablets: 40 and 80 mg

For More Information:
www.latuda.com







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