New Drug Approvals

New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

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

February 13 2019

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...

FDA Approves Darzalex (daratumumab) Split-Dosing Regimen

February 11 2019

Horsham, PA, February 12, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved a split-dosing regimen for Darzalex® (daratumumab), providing...

FDA Approves Cablivi (caplacizumab-yhdp) for Acquired Thrombotic Thrombocytopenic Purpura (aTTP) in Adults

February 06 2019

February 6, 2019 -- The U.S. Food and Drug Administration today approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult...

FDA Approves Jeuveau (prabotulinumtoxinA-xvfs) for Temporary Improvement in the Appearance of Frown Lines

February 01 2019

NEWPORT BEACH, Calif., Feb. 01, 2019 (GLOBE NEWSWIRE) -- Evolus, Inc. (NASDAQ: EOLS) today announced that the U.S. Food and Drug Administration (“FDA”) has approved its lead product, Jeuveau, for the temporary improvement in the...

FDA Approves Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), First Generic of Advair Diskus

January 31 2019

HERTFORDSHIRE, England and PITTSBURGH, Jan. 31, 2019 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) today announced the U.S. Food and Drug Administration (FDA) approval of Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), the...

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

January 28 2019

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...