> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-88/
- Published: 2019-04-21T12:00:00.000Z
- Updated: 2026-09-15T01:21:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5126545

> **DEVICES**  
>  
> FDA has cleared a **Bausch & Lomb** 510(k) for its frequent replacement silicone hydrogel contact lenses made with MoistureSeal Technology.  
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> **Medtronic** has received FDA PMA approval for its MiniMed 530G with Enlite, an artificial pancreas system with Threshold Suspend automation for people with diabetes 16 and older. The company says the device is the first in the U.S. that can automatically stop insulin delivery when sensor glucose values reach a preset level and when the patient doesn’t (respond to the Threshold Suspend alarm. It also uses an Enlite sensor, a continuous glucose sensor with a “31% improvement in overall accuracy from the previous generation.” The sensor can be worn for up to six days.  
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> **Nucletron** has received FDA 510(k) clearance for Esteya, an electronic brachytherapy system for treating skin cancer. The system relies on a small, high-dose rate to apply radiation directly to a cancerous site, the company says.  
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> **HUMAN DRUGS**  
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> FDA has approved a **Baxter Healthcare** NDA for Clinolipid (lipid injectable emulsion, USP) for intravenous feeding (parenteral nutrition) in adult patients who are unable to eat or drink. Clinolipid was granted a priority review to help alleviate a current drug shortage.  
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> **Lupin** has received FDA approval of an ANDA for a generic copy of Allergan’s Zymaxid (gatifloxacin) ophthalmic solution, 0.5%, indicated for treating bacterial conjunctivitis.  
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> FDA has approved a **Takeda Pharmaceuticals** and **Lundbeck** NDA for Brintellix (vortioxetine), indicated for treating adults with major depressive disorder.  
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> **UCB** has received FDA approval for Cimzia (certolizumab pegol) for treating adult patients with active psoriatic arthritis.  
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> **Wyeth Pharmaceuticals** has received FDA approval of an NDA for Duavee (conjugated estrogens/bazedoxifene) for women who suffer from moderate-to-severe hot flashes (vasomotor symptoms) associated with menopause and to prevent osteoporosis after menopause. It is approved only for postmenopausal women who still have a uterus, FDA says.  
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