Tag Archives: approves

FDA Approves Aemcolo (rifamycin) to Treat Travelers’ Diarrhea

FDA Approves Aemcolo (rifamycin) to Treat Travelers’ Diarrhea Print this page November 16, 2018 — The U.S. Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the… Read More »

FDA Approves Newly Formulated OTC Primatene Mist (epinephrine) to Treat Mild Asthma

Print this page RANCHO CUCAMONGA, Calif., Nov. 07, 2018 (GLOBE NEWSWIRE) — Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced today that the U.S. Food and Drug Administration (FDA) granted approval of its New Drug Application (NDA) for Primatene Mist (epinephrine inhalation aerosol bronchodilator suspension), which is delivered by a metered dose inhaler (MDI) with a non-chlorofluorocarbon… Read More »

FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta

FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta Print this page REDWOOD CITY, Calif., Nov. 02, 2018 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (NASDAQ: CHRS), today announced that the U.S. Food and Drug Administration (FDA) has approved Udenyca (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients… Read More »