Drugs

Ocular Therapeutix Addresses Inspection Findings

FDA has told Ocular Therapeutix that corrective actions detailed in a response to an inspection Form 483 appear to address the 10 observations that led to a complete response letter for its NDA on Dextenza (dexamethasone insert) 0.4 mg, for intracanalicular use in treating ocular pain occurring after ophthalmic surgery. The agency’s letter, however, took exception to one response related to the proposed process for identity testing of an incoming inert gas component used in the manufacturing process, the company says. In the letter, FDA also requested that the company provide evidence (e.g., a final report) when migration to automatic integration of analytical testing is complete, which is anticipated during the third quarter.

The complete response letter noted that “satisfactory resolution of the manufacturing deficiencies identified during the FDA facility inspection is required before the NDA may be approved.” It did not identify any efficacy or safety concerns with respect to the clinical data provided in the NDA, nor any need for additional clinical trials for the approval of the NDA, the company says.

Dextenza, which is placed through the punctum, a natural opening in the eye lid, into the canaliculus, and it delivers dexamethasone to the ocular surface for up to 30 days. Following treatment, Dextenza 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