New product newswire
RX
NEW DRUGS
Altana Inc., Florham Park, N.J., (973) 514-4240, has FDA approval for a nasal spray to treat the nasal symptoms of seasonal and perennial allergies. Omnaris (ciclesonide), a corticosteroid, is considered suitable for adults and children over the age of 12. It treats the main symptom of allergic rhinitis: an inflamed, runny nose.
Bradley Pharmaceuticals, Fairfield, N.J., (973) 882-1505, has FDA approval to market Polyphenon E Ointment 15%. The topical ointment is a mixture of catechins extracted from green tea and is indicated for the treatment of external genital and perianal warts caused by certain strains of human papilloma virus.
NEW INDICATIONS
Seroquel (quetiapine fumarate), an atypical antipsychotic from AstraZeneca, Wilmington, Del., (800) 842-9920, has been FDA-approved to treat depressive episodes associated with bipolar disorder. This one medication can now treat both depressive and manic episodes. It is already approved to treat schizophrenia as well as the acute manic episodes of bipolar I disorder.
A new indication has been approved for Noxafil (posaconazole) Oral Suspension, a product of Schering-Plough, Kenilworth, N.J., (908) 298-4000. The drug, which was approved earlier for prevention of invasive Aspergillus and Candida infections in severely immunocompromised patients 13 years of age and older, was recently approved for treating oropharyngeal candidiasis.
NEW FORMULATIONS
GlaxoSmithKline, Research Triangle Park, N.C., (919) 483-2100, has received FDA approval for once-a-day Coreg CR (carvedilol phosphate) extended-release capsules for three new cardiovascular indications: hypertension; post-myocardial infarction left ventricular dysfunction; and mild to severe heart failure. The drug will use Flamel Technologies' Micropump technology to deliver and maintain appropriate amounts of the drug in the body over a 24-hour span. This third-generation beta-blocker works by slowing the heart rate and lowering the force with which it pumps.