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FDA approves Genentech’s Lucentis pre-filled ranibizumab syringe

October 14, 2016 By Sarah Faulkner

GenentechGenentech, a member of the Roche group (PINK:RHHBY), said today that it won FDA clearance for its Lucentis (ranibizumab injection) pre-filled syringes.

The anti-VEGF medicine is FDA-approved to treat wet age-related macular degeneration and macular edema after retinal vein occlusion.

The pre-filled syringe enables physicians to eliminate steps in preparation and administration process, the company reported, such as disinfecting the vial, attaching a filter needle,and drawing the medicine from the vial using the needle.

Physicians have to attach the injection needle to the syringe and adjust to the proper dose, the San Francisco, Calif.-based company said.

“The FDA approval of the Lucentis prefilled syringe marks a new milestone in our ongoing commitment to people affected by vision-threatening eye diseases,” chief medical officer and head of global product development Dr. Sandra Horning said in prepared remarks. “With the PFS, physicians will have a new option for administering Lucentis to the hundreds of thousands of people in the U.S. diagnosed with either wet AMD or macular edema after RVO.”

The Lucentis pre-filled syringe is expected to be available in early 2017.

Filed Under: Food & Drug Administration (FDA), Optical/Ophthalmic, Regulatory/Compliance Tagged With: Genentech, Roche

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