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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-24/
- Published: 2021-10-31T12:00:00.000Z
- Updated: 2026-09-14T17:20:53.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5133015

**DEVICES**

FDA has cleared a **NOWDiagnostics** 510(k) for the AdexusDx hCG point-of-care test, which uses a single drop of capillary or whole blood to quickly and accurately diagnose pregnancy earlier than urine-based tests. The immunoassay is intended for use for the qualitative detection of human chorionic gonadotropin (hCG) in human whole blood, plasma or serum.

**HUMAN DRUGS**

FDA has approved **Baxter International**’s cefazolin injection in its Galaxy container (2 g/100 mL), a flexible container that uses the company’s proprietary aseptic filling manufacturing processes. Cefazolin injection is a cephalosporin antibacterial indicated for preoperative prophylaxis treatment. The drug has been on the agency’s drug shortage list for more than a year due to high demand.

**Purdue Pharma** has received FDA approval of its Oxycontin (oxycodone hydrochloride) extended-release tablets for use in pediatric patients aged 11 to 16 years for managing pain. The agency says that OxyContin should only be used in pediatric patients who have already been treated with an opioid pain medicine.

FDA has approved an expanded use for **Raptor Pharmaceutical** **Corp.**’s Procysbi (cysteamine bitartrate) delayed-release capsules to treat children two to six years of age with nephropathic cystinosis. The drug was previously approved for treating adult and pediatric patients aged six years and older.

FDA has approved a **Taro Pharmaceutical Industries** NDA for Keveyis (dichlorphenamide) 50 mg tablets for treating primary hyperkalemic and hypokalemic periodic paralysis, a group of rare hereditary disorders that cause muscle weakness episodes or paralysis.

**Upsher-Smith Laboratories** has received FDA approval of an ANDA for memantine HCl tablets in 5 mg and 10 mg strength, generic copies of Actavis’ Namenda, which is indicated for treating moderate to severe dementia (Alzheimer’s-related).