Tag Archives: Approves

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

FDA Approves Nexletol (bempedoic acid) to Lower LDL-Cholesterol Print this page 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 medicine. Nexletol is indicated as an adjunct to diet and maximally tolerated… Read More »

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

FDA Approves Pemfexy (pemetrexed for injection) as a Branded Alternative to Alimta Print this page 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 (“FDA”) for its novel product, Pemfexy (pemetrexed for injection),… Read More »

FDA Approves Monoferric (ferric derisomaltose) Injection for the Treatment of Iron Deficiency Anemia

FDA Approves Monoferric (ferric derisomaltose) Injection for the Treatment of Iron Deficiency Anemia Print this page MORRISTOWN, N.J., Jan. 29, 2020 /PRNewswire/ — Pharmacosmos Therapeutics Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved Monoferric® (ferric derisomaltose) injection 100 mg/mL.  Monoferric® is an intravenous iron indicated for the treatment of iron… Read More »

FDA Approves Dayvigo (lemborexant) for the Treatment of Insomnia in Adult Patients

FDA Approves Dayvigo (lemborexant) for the Treatment of Insomnia in Adult Patients Print this page December 23, 2019 — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) today announced that the U.S. Food and Drug Administration (FDA) approved the new drug application for its in-house discovered and developed orexin receptor antagonist Dayvigo (lemborexant). Dayvigo… Read More »

FDA Approves Zulresso (brexanolone) for the Treatment of Postpartum Depression

FDA Approves Zulresso (brexanolone) for the Treatment of Postpartum Depression Print this page March 19, 2019 — The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD. “Postpartum depression… Read More »

F.D.A. Approves First Drug for Postpartum Depression

The first drug for women suffering postpartum depression received federal approval on Tuesday, a move likely to pave the way for a wave of treatments to address a debilitating condition that is the most common complication of pregnancy. The drug works very quickly, within 48 hours — a significant improvement over currently available antidepressants, which… Read More »