Drugs

Ocular Therapeutix Re-files NDA for Dextenza

Ocular Therapeutix has resubmitted its NDA for Dextenza (dexamethasone insert) 0.4mg, indicated for treating ocular pain following ophthalmic surgery. The submission responds to concerns raised in a 7/2017 complete response letter (see earlier story). The agency set a user fee review action target date of 12/28.

The 2017 letter cited deficiencies in manufacturing processes and analytical testing related to manufacturing the drug product for commercial production that had been identified during a pre-NDA approval inspection, according the company. “Satisfactory resolution of the manufacturing deficiencies detailed in the Form FDA-483 is required before the NDA may be approved,” the company said at the time. In 7/2016, another complete response letter was issued and raised concerns pertaining to unspecified deficiencies in the manufacturing process and controls section of the submission.

Dextenza is designed to be placed through the punctum, a natural opening in the eyelid, into the canaliculus for delivering dexamethasone without preservatives to the ocular surface for up to 30 days. Following treatment, the insert resorbs and exits the nasolacrimal system without need for removal.

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