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 Ajovy (fremanezumab-vfrm) for Preventive Treatment of Migraine

September 14 2018

September 14, 2018 -- Today, the US Food and Drug Administration (FDA) approved Ajovy (fremanezumab-vfrm) for the preventive treatment of migraine in adults. Ajovy is the second FDA-approved preventive migraine treatment in a new class of drugs that...

FDA Approves Xelpros (latanoprost ophthalmic emulsion) to Treat Open-angle Glaucoma or Ocular Hypertension

September 14 2018

MUMBAI, India & PRINCETON, N.J.--(BUSINESS WIRE) September 14, 2018 --Sun Pharmaceutical Industries Ltd. and Sun Pharma Advanced Research Company Ltd. (SPARC) today announced U.S. Food and Drug Administration (USFDA) approval for the New Drug...

FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA)

September 13 2018

South San Francisco, CA -- September 13, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra...

FDA Approves Lumoxiti (moxetumomab pasudotox-tdfk) for Hairy Cell Leukemia

September 13 2018

September 13, 2018 -- The U.S. Food and Drug Administration today approved Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have...

FDA Approves Cassipa (buprenorphine and naloxone) Sublingual Film as Maintenance Treatment for Opioid Dependence

September 06 2018

September 7, 2018 -- The U.S. Food and Drug Administration today approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence. This action provides a new dosage strength...

ITF Pharma Announces FDA Approval of Tiglutik (riluzole) Oral Suspension for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

September 06 2018

BERWYN, Pa., Sept. 6, 2018 /PRNewswire/ -- ITF Pharma, a U.S.-based specialty pharmaceutical company and a subsidiary of Italfarmaco, a privately-held European specialty pharmaceutical company, committed to investing in and commercializing impactful...