The FDA issued a non-approvable letter to Replidyne and Forest for their investigational antibiotic faropenem medoxomil. Replidyne submitted an NDA for the drug in Dec. 2005 for four adult indications: acute bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis and uncomplicated skin and skin structure infections.
GlaxoSmithKline and Flamel Technologies announced that the FDA has approved Coreg CR (carvedilol phosphate) extended-release capsules, for the treatment of three cardiovascular conditions -- hypertension, post-myocardial infarction left ventricular dysfunction and mild to severe heart failure.
AstraZeneca’s Seroquel (quetiapine fumarate) won FDA approval for the expanded indication to the treat patients with depressive episodes associated with bipolar disorder.
Novartis’ cancer drug Gleevec won expanded FDA approval to treat five potentially life-threatening diseases. Gleevec can now be prescribed to treat dermatofibrosarcoma protuberans tumors, and four blood diseases: Philadelphia chromosome-positive acute lymphoblastic leukemia, hypereosinophilic syndrome, aggressive systemic mastocytosis and certain forms of myeoloproliferative disorders.
The FDA approved Bristol-MyersSquibb’s new single capsule formulation of Reyataz (atazanavir sulfate) for the treatment of HIV-1 infection in adults as part of combination therapy.
Schering-Plough said the FDA has approved Noxafil (posaconazole) for the treatment of oropharyngeal candidiasis (OPC), including infections refractory to itraconazole and/or fluconazole.
The FDA has granted marketing approval for Altana’s Omnaris (ciclesonide nasal spray). Omnaris is indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 12 years of age and older. In addition, the FDA determined Omnaris approvable for the indication in children ages 2 to 11.