FDA Asks ‘Minor’ Labeling Changes for NRx Ketamine

FDA has asked NRx Pharmaceuticals to submit “minor” changes to the submitted label for the company’s preservative-free ketamine product NRX-100. A company statement says NRx was asked to submit sample labeling with the proposed proprietary name currently under review in advance of the 11/10 GDUFA target action date. The statement says NRX-100 has been awarded Fast Track designation for treating suicidal ideation in depression, including bipolar depression.

Adulterated Drugs at SCA Outsourcing Facility: FDA

A 10/20-10/30/2025 FDA inspection at SCA Pharmaceuticals’ outsourcing facility in Little Rock, AR, found serious deficiencies in the firm’s practices for producing drug products that are intended or expected to be sterile. A just-released 9/14 Warning Letter says the agency investigator collected evidence

Vanda Pharmaceuticals Puts Social Anxiety Drug On Hold

Vanda Pharmaceuticals says its development program for VQW-765, a novel small molecule alpha 7 nicotinic acetylcholine receptor partial agonist, is on hold after the therapy failed to meet its primary endpoint in a Phase 3 clinical study in patients with social anxiety. The study, VP-VQW-765-3201 (Study

Require Postmarket Studies, Registry for Some Anti-Depressants: Petition

The Antidepressant Coalition for Education is petitioning FDA to require postmarketing studies and a national patient registry for selective serotonin reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI). The petition says the patient registry should prospectively follow patients during and after SSRI or SNRI tapering or discontinuation and should

FDA Asks ‘Minor’ Labeling Changes for NRx Ketamine

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Adulterated Drugs at SCA Outsourcing Facility: FDA

Vanda Pharmaceuticals Puts Social Anxiety Drug On Hold

Require Postmarket Studies, Registry for Some Anti-Depressants: Petition

Lowest Job Ranking for FDA: Poll