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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
Aquestive’s NDA Resubmission Accepted for Review
FDA has accepted for review an Aquestive Therapeutics NDA resubmission for Anaphylm (dibutepinephrine) sublingual film for treating Type I allergic reactions, including anaphylaxis. The agency has set a review action target date of 3/16/2027. In January, FDA issued the company a complete response letter (CRL) on the original