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Novartis Pharmaceuticals announced that the FDA has approved prescription Zaditor (ketotifen fumarate ophthalmic solution 0.025 percent), indicated for the temporary prevention of itchy eyes due to allergic conjunctivitis, for OTC use.
Bristol-Myers Squibb (BMS) announced that the FDA has granted approval of a new 300-mg single-capsule formulation of Reyataz (atazanavir sulfate) for the treatment of HIV-1 infection in adults as part of combination therapy.
GlaxoSmithKline (GSK) and Flamel Technologies have announced FDA approval of their once-a-day Coreg CR (carvedilol phosphate) extended-release capsules for the treatment of high blood pressure, post-myocardial infarction and mild to severe heart failure.
The FDA has announced the approval of Altana's Omnaris (ciclesonide) nasal spray, a new drug for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis, commonly known as hay fever, in adults and children 12 and older.
Adeza Biomedical announced that the FDA has determined that Gestiva for the prevention of preterm birth in women with a history of preterm delivery is approvable subject to the completion of an additional animal study and certain other conditions.
Replidyne and Forest Laboratories announced that the FDA has issued a "not approvable" letter for Replidyne's new drug application (NDA) for faropenem medoxomil, an antibiotic.
AM-Pharma has announced the first positive results observed in its multicenter, double-blind, placebo-controlled pilot study in the treatment of sepsis with its patented alkaline phosphatase (AP) drug, Verum.
Osiris Therapeutics announced positive results from a pilot Phase II study using Prochymal for the treatment of patients with moderate to severe Crohn's disease who had failed to respond to standard treatments such as steroids and Remicade (infliximab).
NeurogesX has announced positive results from a multicenter, double-blind, controlled Phase III trial of Transacin (NGX-4010), the company's high-concentration trans-capsaicin dermal patch, in patients with post-herpetic neuralgia (PHN).