FDA approves expanded use of exenatide injection
October 21st 2011FDA has approved exenatide (Byetta, Amylin and Eli Lilly) injection as an add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione, in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone.
FDA approves bupivacaine hydrochloride injection, USP
October 20th 2011FDA has approved bupivacaine hydrochloride injection, USP (Sagent and Strides Arcolab), a local or regional anesthetic, for use in surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and obstetrical procedures.
FDA approves Combivent Respimat Inhalation Spray for patients with COPD
October 10th 2011FDA has approved ipratropium bromide and albuterol (Combivent Respimat Inhalation Spray, Boehringer Ingelheim), for COPD patients using a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.
FDA approves Botox to treat a form of urinary incontinence
September 2nd 2011FDA has approved onabotulinumtoxinA (Botox, Allergan) for injection for the treatment of urinary incontinence resulting from detrusor overactivity associated with a neurologic condition (eg, spinal cord injury [SCI], multiple sclerosis [MS]) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
FDA approves crizotinib with companion diagnostic for a type of late-stage lung cancer
August 30th 2011FDA has approved crizotinib (Xalkori, Pfizer), the first and only therapy specifically for patients with locally advanced or metastatic non-small-cell lung cancer that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
Late-breaking news: FDA approves Solesta for fecal incontinence in adult patients
May 31st 2011FDA has approved a sterile, injectable gel (Solesta, Oceana Therapetucis) as a treatment for fecal (bowel) incontinence in adult patients who have not responded to conservative therapy such as dietary control.
FDA approves Sutent for advanced pancreatic neuroendocrine tumors
May 27th 2011FDA has approved sunitinib malate (Sutent, Pfizer) as the first anti-vascular endothelial growth factor therapy to treat progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease.
Late-breaking news: FDA approves rilpivirine for HIV-1 infection in treatment-naive adults
May 20th 2011FDA has approved rilpivirine (Edurant, Tibotec Therapeutics, a division of Centocor Ortho Biotech) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy.