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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-71/
- Published: 2018-05-27T12:00:00.000Z
- Updated: 2026-09-15T00:08:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141494

**DEVICES**

FDA has cleared an Additive Orthopedics 510(k) for its Patient Specific 3D Printed Bone Segments for internal bone fixation in the ankle and foot. “Our lattice structures are proving to be the next generation design as opposed to the older, more open, types of structures that rely on biologics for osteosynthesis,” the company says. “In several patients, our lattice structures have shown close to 90% boney in-growth after six months using no biologics.”

FDA has cleared a MC10 510(k) for its BioStamp nPoint system, a wireless, biometric data collection platform intended for use by healthcare professionals and researchers for continuous collection of physiological data in the home or traditional healthcare settings. The device is designed for use in clinical trials and research studies where collection of relevant data is needed.

**DRUGS**  
  
FDA has approved an Amgen BLA for Aimovig (erenumab), a once-monthly self-injection for preventing migraines in adults. Aimovig is the first monoclonal antibody targeting the calcitonin gene-related peptide receptor approved for migraines, an [agency release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608120.htm?ref=fdaweb.com) says.

FDA has approved an Amneal Pharmaceuticals ANDA for a generic version of Daiichi Sankyo’s Welchol (colesevelam HCI) tablets, 625 mg. The product is approved along with diet and exercise for lowering LDL or “bad” cholesterol. It can be taken alone or with other statin cholesterol-lowering drugs. Welchol had annual U.S. sales of about $526 million last year.

FDA has approved a U.S. WorldMeds NDA for Lucemyra (lofexidine hydrochloride) for mitigating withdrawal symptoms in adults who have abruptly discontinued opioid use. FDA says that this is the first non-opioid treatment for managing opioid withdrawal symptoms, but it may only lessen the severity and is only approved for treatment for up to 14 days.