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."
Mylan on Thursday announced that the U.S. District Court for the district of New Jersey granted its motion for a permanent injunction against GlaxoSmithKline in relation to paroxetine CR, the generic version of GSK's Paxil CR.
RetireSafe, a grassroots organization advocating on behalf of America’s seniors on Tuesday released a survey finding that seniors overwhelmingly support strong patient safeguards for biosimilar medications.
Teva Pharmaceuticals on Monday announced that the Food and Drug Administration has accepted the company's new drug application for albuterol multi-dose dry-powder inhaler, a breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease.
Anacor Pharmaceuticals announced that the Food and Drug Administration has approved the company's new drug application for Kerydin (tavaborole) topical solution, 5% — an antifungal approved for the topical treatment of onychomycosis of the toenails.