PharmaJet, the developer of a needle-free injection technology to administer medications and vaccines to patients, and bioCSL, the maker of Afluria (influenza vaccine) on Tuesday announced the Food and Drug Administration has approved the PharmaJet Stratis 0.5mL Needle-Free Jet Injector for delivery of Afluria in individuals ages 18 years to 64 years.
The Food and Drug Administration has granted tentative approval for Basaglar (insulin glargine injection), which is used to improve glycemic control in adults with Type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with Type 1 diabetes.
The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities.
The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved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.
Following Walgreens' decision to acquire the rest of the Alliance Boots business — and to keep its headquarters based in the greater Chicago area — Sen. Dick Durbin, D-Ill., weighs in on the decision in a brief video.
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.
New York City's Department of Health and Mental Hygiene said a man who was tested for Ebola at Mount Sinai Hospital is "unlikely" to have the virus. The patient was admitted to the hospital early Monday with a fever and gastrointestinal problems. He recently visited a West African country where Ebola was reported, according to the Washington Post.
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.