Pharmacy Times

Rx Product News

Author:

HOT Rx



Twynsta

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

Indication:
Boehringer Ingelheim Pharmaceuticals recently announced that the FDA approved a new drug application for Twynsta (telmisartan/ amlodipine) Tablets for the treatment of hypertension alone or in combination with other antihypertensive agents, or as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals. Twynsta is an angiotensin II receptor blocker and a dihydropyridine calcium channel blocker combination product. Dosage should be initiated at 40/5 mg or 80/5 mg once daily.

Dosage Form:
Tablets: 40/5, 40/10, 80/5, 80/10 mg

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



Agriflu

Marketed by:
Novartis Vaccines and Diagnostics Inc (Siena, Italy)

Indication:
The FDA recently approved Agriflu seasonal influenza vaccine for individuals aged 18 years and older to prevent disease caused by influenza virus subtypes A and B. Agriflu is administered as a single injection in the upper arm and is available in single-dose, prefilled syringes that do not contain preservatives. Individuals with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

Dosage Form:
Sterile suspension for injection: 0.5-mL single-dose prefilled syringes with no preservative

For More Information:

www.fda.gov



ACTEMRA


Marketed by:
Genentech Inc (South San Francisco, CA)

Indication:

Genentech Inc, a wholly owned member of the Roche Group, announced that the FDA approved ACTEMRA (tocilizumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to 1 or more tumor necrosis factor antagonist therapies. The product is the first interleukin-6 receptor-inhibiting monoclonal antibody approved to treat RA. ACTEMRA may be used alone or in combination with methotrexate or other disease-modifying antirheumatic drugs.

Dosage Form:
Single-use vials of ACTEMRA (20 mg/mL): 80 mg/4 mL; 200 mg/10 mL; 400 mg/20 mL

For More Information:
www.actemra.com
800-ACTEMRA (800-228-3672)



ISTODAX

Marketed by:
Gloucester Pharmaceuticals Inc (Cambridge, MA)

Indication:
The FDA recently approved ISTODAX (romidepsin), which is indicated for treatment of cutaneous T-cell lymphoma in patients who have received at least 1 prior systemic therapy. ISTODAX is a member of a new class of cancer drugs known as histone deacetylase inhibitors. The recommended dose of ISTODAX is 14 mg/m2 administered intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle. Cycles should be repeated every 28 days, provided that the patient continues to benefit from and tolerates the therapy.

Dosage Form:
ISTODAX for injection, 10 mg, supplied with 1 diluent vial containing 2 mL (deliverable volume) of solution

For More Information:
www.istodax.com
866-223-7145



Pennsaid

Marketed by:
Covidien (St. Louis, MO) and Nuvo Research (Mississauga, Ontario)

Indication:
Covidien and Nuvo Research announced FDA approval of the new drug application for Pennsaid Topical Solution (diclofenac sodium topical solution) 1.5% w/w. Pennsaid Topical Solution is a nonsteroidal anti-inflammatory drug (NSAID) used for the treatment of signs and symptoms of osteoarthritis of the knee. The product is an NSAID of the arylacanoic acid group. The mode of action is not fully known, but it is considered to be primarily through its inhibitory effects on prostaglandin synthesis by interfering with the action of prostaglandin synthetase/cyclooxygenase, isoforms 1 and 2.

Dosage Form:
Diclofenac sodium 1.5% w/w supplied in 15-, 30-, 60-, and 120-mL bottles

For More Information:
www.covidien.com
www.nuvoresearch.com



Revatio

Marketed by:
Pfizer Inc (New York, NY)

Indication:
The FDA recently approved Revatio (sildenafil) Injection, an intravenous formulation of Revatio. Revatio Injection is for the continued treatment of patients with pulmonary arterial hypertension (PAH) who are currently prescribed Revatio tablets but who are currently unable to take oral medication. Revatio is indicated for the treatment of adult patients with PAH (WHO Group I) to improve exercise ability and delay clinical worsening. Revatio is the only phosphodiesterase-5 inhibitor available in both tablet and intravenous formulations.

Dosage Form:

Injection: 10 mg (12.5 mL) single-use vial (Also available in 20-mg tablets)

For More Information:
www.revatio.com



VIBATIV

Marketed by:
Astellas Pharma US Inc (Deerfield, IL) and Theravance Inc (South San Francisco, CA)

Indication:
Theravance Inc and Astellas Pharma US Inc announced that the FDA approved VIBATIV (telavancin) for the treatment of adult patients with complicated skin and skin structure infections caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin- resistant and methicillin-susceptible strains. VIBATIV is a bactericidal, once-daily injectable lipoglycopeptide antibiotic with a dual mechanism of action, whereby VIBATIV both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function.

Dosage Form:
Single-use vials containing 250 or 750 mg telavancin

For More Information:
www.vibativ.com



ZYPREXA RELPREVV

Marketed by:
Eli Lilly and Co (Indianapolis, IN)

Indication:

The FDA recently approved ZYPREXA RELPREVV (olanzapine) for Extended-Release Injectable Suspension for the treatment of schizophrenia in adults. The product is a long-acting intramuscular injection that sustains the delivery of olanzapine for up to 4 weeks. ZYPREXA RELPREVV is intended for deep intramuscular gluteal injection only. Dosages may include the following: 150 mg/2 weeks, 210 mg/2 weeks, 300 mg/2 weeks, 300 mg/4 weeks, or 405 mg/4 weeks. Note that 2 ZYPREXA RELPREVV intramuscular formulations exist with different dosing schedules. ZYPREXA IntraMuscular (10 mg/vial) is a short-acting formulation and should not be confused with ZYPREXA RELPREVV.

Dosage Form:

Powder for suspension for intramuscular use only: 210 mg/vial, 300 mg/vial, and 405 mg/vial

For More Information:
www.zyprexarelprevv.com