Tag Archives: approves

FDA Approves Egaten (triclabendazole) for the Treatment of Fascioliasis, a Neglected Tropical Disease

Print this page Basel, Switzerland, February 13, 2019 – Novartis announced today that the US Food and Drug Administration (FDA) has approved Egaten (triclabendazole) for the treatment of fascioliasis in patients six years of age and older. This makes Egaten the only FDA-approved drug for people with this disease and is expected to facilitate broader… Read More »

FDA Approves Osphena (ospemifene) for Moderate to Severe Vaginal Dryness Due to Menopause

Print this page BLAINVILLE, QC, January 29, 2019 – Duchesnay Inc., a pharmaceutical company specializing in women’s health, announced today that the FDA has approved its supplemental New Drug Application (sNDA) seeking to add moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy (VVA), due to menopause, to the indication of Osphena… Read More »

FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin

Home News New Drugs FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin Print this page January 18, 2019 — FDA today approved Ontruzant (trastuzumab-dttb), a biosimilar to U.S.-licensed Herceptin (trastuzumab). A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-FDA approved biological product,… Read More »