FDA approves first adjuvanted vaccine for prevention of H5N1 avian influenza for National Stockpile
November 25th 2013FDA approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu. The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in people aged 18 years and older who are at increased risk of exposure to the H5N1 influenza virus.
Under breakthrough therapy designation, FDA approves chronic lymphocytic leukemia drug
November 1st 2013FDA has approved obinutuzumab (Gazyva, Genentech, a member of the Roche Group), also known as GA101, in combination with chlorambucil chemotherapy for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).
First generic capecitabine approved for colorectal and breast cancers
September 18th 2013FDA has approved the oral chemotherapy tablet capecitabine, the first generic version of Teva’s Xeloda, to treat cancer of the colon or rectum that has spread to other parts of the body. It also approved generic capecitabine for treatment of metastatic breast cancer.
FDA approves first rapid diagnostic test to detect HIV-1 antigen, HIV-1/2 antibodies
August 9th 2013FDA has approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens (The Alere Determine HIV-1/2 Ag/Ab Combo, Orgenics, Ltd. (an Alere, Inc. company) was approved.
FDA approves new treatment for a type of late-stage lung cancer
July 15th 2013FDA has approved afatinib (Gilotrif, Boehringer Ingelheim) for patients with late-stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.
FDA approves sublingual agent for treatment of opioid dependence
July 9th 2013FDA has approved a once-daily buprenorphine/naloxone (Zubsolv, Orexo) sublingual tablet CIII for use as maintenance treatment for people with opioid dependence. It should be used as part of a complete treatment plan that includes counseling and psychosocial support.
FDA approves first nonhormonal treatment for hot flashes associated with menopause
July 1st 2013FDA has approved low-dose paroxetine capsules (Brisdelle, Noven Pharmaceuticals), 7.5 mg/day, for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, also referred to as hot flashes and night sweats.
FDA approves Vibativ for hospitalized patients with bacterial pneumonia
June 26th 2013FDA has expanded the use of telavancin (Vibativ, Theravance) to treat adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable.
New test identifies HCV genotypes
June 21st 2013FDA approved a test that identifies the genotype of hepatitis C virus (HCV) that a patient is carrying. The Abbott RealTime HCV Genotype II (Abbott Molecular) can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5 using a sample of an infected patient’s blood plasma or serum, which will aid healthcare professionals in determining the appropriate approach to treatment, resulting in better patient outcomes. Various HCV genotypes respond differently to available drug therapies.