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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-81/
- Published: 2019-02-03T12:00:00.000Z
- Updated: 2026-09-15T00:59:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138637

**DRUGS**

FDA has approved a **Mitsubishi Tanabe Pharma America** NDA for Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis, commonly known as Lou Gehrig’s disease. The intravenous infusion is intended to be administered with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period. Approval was based on data from a six-month clinical trial conducted in Japan. “

FDA has approved a **Takeda Pharmaceutical Co.** NDA for Alunbrig (brigatinib) for treating patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer who have progressed on or are intolerant to crizotinib. The accelerated approval was based on tumor response rate and duration of response shown in a trial called ALTA trial.

**DEVICES**

FDA has approved a **Cardiovascular Systems** PMA supplement for a redesigned saline pump used as part of its Diamondback 360 Orbital Atherectomy Systems. The 70057-03 Saline Infusion Pump will replace CSI’s 7-10014 Saline Infusion Pump, which the company recalled last month. The company anticipates replacing all recalled units by no later than 8/31.

FDA has approved a **Medtronic** PMA for the Resolute Onyx Drug-Eluting Stent (DES) in 4.5 mm and 5.0 mm sizes to treat patients with large coronary anatomies. The company says the device is the first DES to feature core wire technology, a stent manufacturing method that involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct the device.