FDA Policy/General

Product Approval Summaries

DEVICES

FDA has cleared a Bausch & Lomb 510(k) for its frequent replacement silicone hydrogel contact lenses made with MoistureSeal Technology.

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.

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.

HUMAN DRUGS

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.

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.

FDA has approved a Takeda Pharmaceuticals and Lundbeck NDA for Brintellix (vortioxetine), indicated for treating adults with major depressive disorder.

UCB has received FDA approval for Cimzia (certolizumab pegol) for treating adult patients with active psoriatic arthritis.

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.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome