Astellas Pharma won FDA approval for their sNDA for the use of Mycamine (micafungin sodium) for injection in the treatment of patients with candidemia, acute disseminated candidiasis, candida peritonitis and abscesses.
Product news
January 17, 2008
5:00 am
Nycomed said the FDA has approved Alvesco (ciclesonide) inhalation aerosol in the US for the maintenance treatment of asthma and as prophylactic therapy in adult and adolescent patients aged 12 years and older.
Product news
January 10, 2008
5:00 am
Canadian health officials have approved Merck’s Januvia (sitagliptin phosphate monohydrate), a once-daily, oral medication in a new class of anti-hyperglycemic agents known as DPP-4 (dipeptidyl peptidase-4) inhibitors.
Dossier offers one-stop shop for new drug insights
December 6, 2007
5:00 am
Introduced last week, MM&M’s New Drug Dossier is enjoying a successful debut, as pharmaceutical marketers continue to recognize the utility of this business intelligence tool.
MM&M launches New Drug Dossier
November 30, 2007
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MM&M’s New Drug Dossier is designed to give pharmaceutical marketers authoritative promotional and clinical insights on the latest new molecular entities in one online resource.
Product news
November 27, 2007
5:00 am
Bristol-Myers Squibb Company and Otsuka Pharmaceutical announced that the FDA approved the supplemental New Drug Application for Abilify (aripiprazole) as adjunctive, or add-on, treatment to antidepressant therapy in adults with major depressive disorder (MDD).
Product news
November 15, 2007
5:00 am
Roche announced that the FDA has approved Mircera (methoxy polyethylene glycol-epoetin beta) for the treatment of anemia associated with chronic renal failure (CRF) in adults, including patients on dialysis and patients not on dialysis.
Product news
November 13, 2007
5:00 am
AstraZeneca announced that the FDA has approved Crestor (rosuvastatin calcium) as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol.
The FDA said today it has approved Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg) as an OTC product for adults and children 12 years of age and older.
Product news
October 25, 2007
4:00 am
The FDA has granted marketing approval to Genzyme for its Renvela treatment for the control of serum phosphorus in patients with chronic kidney disease on dialysis.