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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-87/
- Published: 2019-04-14T12:00:00.000Z
- Updated: 2026-09-15T01:20:12.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5129485

**BIOLOGICS**

**Baxter International** has received FDA approval for Flexbumin \[Albumin (Human)\] USP 5% Solution. indicated for hypovolemia hypoalbuminemia due to general causes burns and in patients undergoing cardiopulmonary bypass surgery.

**DEVICES**

FDA has cleared **ElMindA Ltd’s** BNA Analysis System for assessing brain function in 14 to 24 year-olds. According to the company, Brain Network Activity (BNA) combines non-invasive, multi-channel EEG technology with sophisticated signal processing and analysis algorithms to measure patterns of brain networks activated during specific brain processes and deliver both quantitative and qualitative insights into brain functionality. The company says the BNA output allows healthcare providers to assess a patient’s functional brain network activity compared to the activity of healthy brains.

FDA has cleared **Randox’s** Acusera Immunoassay Premium Plus, a multi-analyte quality control that combines 52 analytes including tumour markers, hormones, therapeutic drugs and Vitamin D.

**HUMAN DRUGS**

**Lannett** has received FDA approval of an ANDA for oxycodone HCl capsules, the equivalent of **Lehigh Valley Technologies Inc.’s** listed reference Oxycodone HCl Capsules, indicated for moderate to moderately severe pain.