Tag Archives: Approves

FDA Approves Qdolo (tramadol hydrochloride) Oral Solution for the Management of Severe Pain

FDA Approves Qdolo (tramadol hydrochloride) Oral Solution for the Management of Severe Pain Print this page ATHENS, Ga., Sept. 8, 2020 /PRNewswire/ — Athena Bioscience, LLC, a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Qdolo™ (tramadol hydrochloride) Oral Solution 5mg/1mL C-IV, an opioid agonist indicated in adults… Read More »

FDA Approves Xeglyze (abametapir) Lotion for the Treatment of Head Lice

FDA Approves Xeglyze (abametapir) Lotion for the Treatment of Head Lice Print this page HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE) July 27, 2020 –Dr. Reddy’s Laboratories Ltd. today announced approval of Xeglyze (abametapir) lotion, 0.74%, a 505(b)(1) NDA by the U.S. Food and Drug Administration. The approval triggers the contractual pre-commercialization milestone of $ 20… Read More »

FDA Approves Rukobia (fostemsavir) for HIV in Adults with Few Treatment Options Available

FDA Approves Rukobia (fostemsavir) for HIV in Adults with Few Treatment Options Available Print this page July 2, 2020 — ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg… Read More »

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

FDA Approves Anjeso (meloxicam injection) for the Management of Moderate to Severe Pain Print this page 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 Application (NDA)… Read More »