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 Vyepti (eptinezumab-jjmr) Intravenous Injection for the Preventive Treatment of Migraine

February 22 2020

Valby, Denmark, February 22, 2020 – H. Lundbeck A/S today announced that Vyepti (eptinezumab-jjmr) has been approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults and will be available in...

FDA Approves Nexletol (bempedoic acid) to Lower LDL-Cholesterol

February 21 2020

ANN ARBOR, Mich., Feb. 21, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) announced today that the U.S. Food and Drug Administration (FDA) approved Nexletol™ (bempedoic acid) tablet, an oral, once-daily, non-statin (LDL-C) lowering...

FDA Approves Anjeso (meloxicam injection) for the Management of Moderate to Severe Pain

February 20 2020

MALVERN, Pa., Feb. 20, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug...

Horizon Therapeutics plc Announces U.S. FDA Approval of New Dosage Form for Procysbi (Cysteamine Bitartrate) Delayed-Release Oral Granules

February 18 2020

DUBLIN--(BUSINESS WIRE)--February 18, 2020 -- Horizon Therapeutics plc (Nasdaq: HZNP) announced today that the U.S. Food and Drug Administration (FDA) has approved Procysbi® (cysteamine bitartrate) delayed-release oral granules in packets for...

FDA Approves Twirla (levonorgestrel and ethinyl estradiol) Contraceptive Patch

February 13 2020

PRINCETON, N.J., Feb. 14, 2020 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (Nasdaq: AGRX) (Agile or the Company), a forward-thinking women’s healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved...

FDA Approves Pemfexy (pemetrexed for injection) as a Branded Alternative to Alimta

February 10 2020

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE) February 10, 2020 --Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that it has received final approval from the U.S. Food and Drug Administration...