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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-12/
- Published: 2020-07-19T12:00:00.000Z
- Updated: 2026-09-14T16:21:39.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139266

**DEVICES**

FDA has approved a Bracco Diagnostics PMA for Aribar Nectar (barium sulfate) oral suspension for use in modified barium swallow (MBS) examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients with known or suspected swallowing disorders. The product is designed to provide “adequate visibility of anatomical structures and the swallowing process during the MBS examination, and simulate different liquid and food consistencies to assess the type and severity of the swallowing disorder,” the company says.

FDA has approved a Quantel Medical PMA for the Easyret fully integrated 577nm yellow photocoagulator, indicated for use to treat certain forms of macular edema and peripheral retinal pathologies. The device is based on Quantel’s proprietary ELBA fiber laser technology, which “delivers pure 577nm yellow wavelength in a uniform top-hat laser spot profile, making it ideal for ophthalmic applications,” the company says. The device has a broad range of settings for treating diabetic retinopathy, macular edema and central serous chorioretinopathy, it adds.

**DRUGS**

FDA has approved a GlaxoSmithKline supplemental BLA for a new subcutaneous formulation of Benlysta (belimumab) for treating adult patients with active, autoantibody-positive Systemic Lupus Erythematosus (SLE) who are receiving standard therapy. SLE is the most common form of lupus, a chronic, incurable autoimmune disease.

FDA has approved a Teligent ANDA for generic erythromycin topical gel, an antibiotic for treating skin infections. Based on recent QuintilesIMS Health data from 5/2017, the market for this product is about $17.6 million.