FDA takes action in October

In October, the FDA approved, cleared, responded to and issued review status for products and devices in the ophthalmic space. Here are the articles:

1. Allergan receives approval for Restasis Multidose

Allergan announced it has received FDA approval for Restasis Multidose, a preservative-free, multidose bottle offering the same formulation as Restasis for patients with chronic dry eye who need to make more of their own tears. Read more

2. Lucentis prefilled syringe approved

Genentech’s pre-filled Lucentis (ranibizumab injection) syringe has been approved by the FDA. Read more

3. Nidek’s MP-3 microperimeter cleared

The FDA issued 510(k) clearance for Nidek’s MP-3 microperimeter to measure local retinal sensitivity for functional assessment of the retina. Read more

4. Nicox to resubmit cetirizine NDA after manufacturing concerns are addressed

Nicox S.A. announced that it received a complete response letter from the FDA regarding the new drug application for AC-170 as a result of an inspection at a third-party facility that produces the active pharmaceutical agent, cetirizine, and supplies it to the manufacturer of the finished product. Read more

5. Priority review for Lucentis for myopic CNV granted

The FDA accepted a supplemental biologics license application and granted priority review for Lucentis for the treatment of myopic choroidal neovascularization. Read more