Enforcement Report - Week of May 24, 2023
SHORT HILLS, N.J.--(BUSINESS WIRE)--Bayshore Pharmaceuticals, LLC is pleased to introduce three new FDA-approved products to their expanding portfolio.
VIRTUAL -- July 17, 2021 -- Ketotifen is effective in management of the childhood syndrome PFAPA (periodic fever, aphthous stomatitis, pharyngitis, adenitis), according to a study presented at the Virtual 2021 Annual Congress of the European Academy of Allergy and Clinical Immunology (EAACI).
Enforcement Report for Week of October 7, 2020
Bausch's Generic Ketotifen Fumarate Receives Approval In US
Bausch Health Companies Inc. (Bausch Health), Bausch + Lomb, a leading global eye health business, and Eton Pharmaceuticals, Inc. announced that the US Food and Drug Administration (FDA) has approved Alaway Preservative Free (ketotifen fumarate) ophthalmic solution, 0.035%, antihistamine eye drops (EM-100), as the first over-the-counter (OTC) preservative-free formulation eye drop approved to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander, which is one of the eye symptoms that affects approximately 80 per cent of people with allergies. Preservatives commonly used in eye drops can cause allergic reactions in some people that can lead to redness, irritation, itching or tearing.
Department of Health and Social Care (DHSC) has issued a medicine supply notification for ketotifen 1mg/5ml elixir (Zaditen)
Bayshore Pharms` Generic Ketotifen Fumarate Receives Approval in US
Johnson & Johnson Vision has unveiled new phase 3 data from two clinical studies of its antihistamine-releasing contact lens, showing that it was able to reduce feelings of itchy eyes after exposure to allergens.