Drugs

Cingulate Resubmits NDA on ADHD Drug

Cingulate says it has resubmitted its NDA for CTx-1301, an investigational treatment for attention-deficit/hyperactivity disorder. The filing addresses issues the agency raised in a June-issued complete response letter, which reportedly were limited to requests for additional chemistry, manufacturing and controls (CMC) information, according to the company. It notes that the letter did not identify any current issues related to the drug's clinical safety or efficacy.

CTx-1301 is a once-daily formulation of dexmethylphenidate hydrochloride that uses Cingulate's proprietary Precision Timed Release technology to deliver three scheduled releases of medication throughout the day. The company is pursuing approval through FDA's 505(b)(2) regulatory pathway.

According to Cingulate, work to address the manufacturing-related questions was conducted with its unnamed production partner.

USV Private Limited CGMP Violations

A 4/7-4/17 FDA inspection at the USV Private Limited drug manufacturing facility in Dabhel, Daman, Dadra and Nagar Haveli and Dam, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/2 Warning Letter says the specific violations were: · failure to

New CDER Clin-Pharm Review Procedures for NDA/BLA Submissions

Cancer Trials Guide Calls for Broader Eligibility, Flexible Dose Escalation

FDA is recommending less restrictive patient eligibility criteria and more flexible dose-escalation strategies in early-phase clinical trials for solid tumors, under a new draft guidance addressing common deficiencies identified during the agency's review of INDs. The draft guidance, Early-Phase IND Protocol Recommendations for Solid Tumors,

Newer Approach Could Help Biosimilar Development: FDA

FDA researchers say there have been global efforts to streamline biosimilar development of therapeutic proteins (TPs) by reducing reliance on comparative efficacy studies and moving instead toward a comparative analytic assessment plus pharmacokinetics approach. Writing in the open-source Clinical Pharmacology & Therapeutics, the researchers say the new approach is

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USV Private Limited CGMP Violations

New CDER Clin-Pharm Review Procedures for NDA/BLA Submissions

Cancer Trials Guide Calls for Broader Eligibility, Flexible Dose Escalation

Newer Approach Could Help Biosimilar Development: FDA