The recent release of Colgate Total’s application submitted to the Food and Drug Administration, which included 35 pages summarizing toxicology studies on triclosan, is raising some eyebrows as some are wondering if the FDA did its due diligence in approving Total 17 years ago, according to a report from Bloomberg Businessweek.
The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act, Bloomberg BNA reported.
Michael Taylor, who currently serves as the Food and Drug Administration's deputy commissioner for foods and veterinary medicine, outlined the importance for companies to adhere to gluten-free guidelines in a post on FDA Voice.
The Food and Drug Administration approved Striverdi Respimat (olodaterol) inhalation spray for the treatment of chronic obstructive pulmonary disease, including chronic bronchitis and/or in patients with emphysema that are experiencing airflow obstruction, the agency announced.
Perrigo on Wednesday announced that it has filed an abbreviated new drug application with the Food and Drug Administration for desoximetasone topical spray 0.25%. The company also has notified Taro Pharmaceuticals U.S.A., the owner of the reference listed drug, of the filing.
The Food and Drug Administration on Wednesday announced approval for Zydelig (idelalisib) to treat patients with chronic lymphocytic leukemia, relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma.
The Food and Drug Administration on Thursday announced the approval of Ruconest, a recombinant C1-Esterase inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema.
About 30% of top-performing OTC drugs today were once prescription-only medications noted Dave Wendland, VP Hamacher Resource Group, on Thursday during a videocast hosted by GMDC titled "Rx-to-OTC: Getting it Right at Retail."