FDA approves gabapentin enacarbil for RLS
April 15th 2011FDA has approved gabapentin enacarbil (Horizant Extended-Release Tablets, GlaxoSmithKline and XenoPort), a once-daily treatment for moderate-to-severe restless legs syndrome, also known as Ekbom disease. It is the first medication in its class to be approved for this condition.
FDA approves Sylatron for injection for adjuvant treatment of melanoma
April 12th 2011FDA has approved peginterferon alfa-2b (Sylatron, Merck) for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.
FDA advisory committee recommends approval of once-daily bronchodilator for COPD
March 9th 2011FDA's Pulmonary-Allergy Drugs Advisory Committee voted to approve Novartis' QAB149 (indacaterol) 75 µg as a once-daily long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema, PR Newswire reported.
FDA approves guanfacine ER tablets to treat ADHD in children, teens
March 4th 2011FDA approved the use of once-daily guanfacine (Intuniv, Shire) extended-release tablets as adjunctive therapy to stimulants for the treatment of attention deficit hyperactivity disorder in children and adolescents aged 6 to 17 years as part of a total treatment program.
FDA approves drug to prevent premature births
February 11th 2011FDA has approved hydroxyprogesterone caproate injection (Makena [formerly known as Gestiva], Hologic and KV Pharmaceutical Co.), the first drug to help prevent premature delivery before 37 weeks in women who have had at least 1 previous preterm birth.
Eisai receives CRL for GERD drug
February 2nd 2011FDA has issued a complete response letter to Eisai for its rabeprazole sodium extended-release capsules, 50 mg, an investigational proton pump inhibitor (PPI) under review for the healing and long-term maintenance of healing and symptom resolution of erosive GERD, and for the treatment of daytime and nighttime heartburn and other symptoms of non-erosive GERD.
FDA issues CRL for obesity treatment due to concerns about cardiovascular safety
February 2nd 2011FDA has issued a complete response letter for Orexigen?s and Takeda?s Contrave (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.
Recombinant HPV Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)
February 1st 2011New indication: Recombinant HPV quadrivalent (types 6, 11, 16, and 18) vaccine (Gardasil) was approved for the prevention of anal cancer and associated precancerous lesions due to HPV in persons aged 9 to 26 years.