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A new flu vaccine, Fluarix (influenza virus vaccine), has received FDA approval and will be available for the upcoming 2005-06 flu season. Fluarix is indicated for adults age 18 and older and will be available in prefilled Tip-Lok syringes.
A new flu vaccine, Fluarix (influenza virus vaccine), has received FDA approval and will be available for the upcoming 2005-06 flu season. Fluarix is indicated for adults age 18 and older and will be available in prefilled Tip-Lok syringes. The maker is GlaxoSmithKline, Pittsburgh, (888) 825-5249.
From Solvay Pharmaceuticals, Marietta, Ga., (770) 578-9000, and CV Therapeutics, Palo Alto, Calif., (650) 384-8500, comes word of the approval of a new indication for Aceon (perindopril erbumine) Tablets. Aceon, originally approved to treat essential hypertension, can now be used for the treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. Solvay will manufacture and distribute the medication; CV Therapeutics will sell and promote it.
CoTherix, South San Francisco, (650) 808-6500, has had its supplemental NDA approved to include on its Ventavis (iloprost) Inhalation Solution labeling that the drug can now be used in combination with Actelion's Tracleer (bosentan) for treating pulmonary arterial hypertension (PAH). Ventavis was approved late last year as monotherapy in the treatment of PAH in patients with New York Heart Association Class III or IV symptoms.
The FDA has approved a new formulation of Alphagan (brimonidine tartrate ophthalmic solution). Alphagan P 0.1% was developed to ensure maximal efficacy of brimonidine with the least drug exposure possible, according to the company. The drug is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The original Alphagan was approved in 0.2% strength, followed by Alphagan P in 0.15% strength.
Caraco Pharmaceuticals, Detroit, (313) 871-8400, is adding clozapine 50-mg tablets to its already approved 25- and 100-mg strengths in its clozapine line. The atypical antipsychotic drug provides a generic equivalent to Novartis' Clozaril, indicated for use in treatment-resistant schizophrenia and to reduce the risk of recurrent suicidal behavior in schizophrenia or schizoaffective disorders.
Making it easier for pharmacists to dispense the customary prescribed course of treatment for children is the new 4-oz. bottle of Clarinex (desloratadine) Syrup, 0.5 mg per 1 mL. The medication is indicated for the relief of symptoms associated with seasonal allergic rhinitis in children two years of age and older and perennial allergic rhinitis and chronic idiopathic urticaria in children as young as six months of age. The maker is Schering-Plough Corp., Kenilworth, N.J., (908) 298-4000.
Zmax (azithromycin extended release) for oral suspension is now available in pharmacies nationwide. The antibiotic therapy, approved in June for treatment of certain types of respiratory infections in adults, is a one-dose, full-course therapy indicated for acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae and community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients for whom oral therapy is appropriate. Zmax is a product of Pfizer Inc., New York City, (800) 438-1985.
Mutual Pharmaceutical Co., Philadelphia, (800) 523-3684, has been granted approval for quinine sulfate capsules, 324 mg. The anti-malarial agent is indicated for the treatment of uncomplicated Plasmodium falciparum malaria.