MHRA reclassifies several drugs
This article was originally published in The Tan Sheet
Executive Summary
The U.K. Medicines and Healthcare products Regulatory Agency eases restrictions on several medicines, including switching to nonprescription sale alclometasone dipropionate 0.05 percent for the short-term treatment of eczema and dermatitis in consumers 12 years and older. The agency also will allow the general sale (equivalent to OTC in the U.S.) of terbinafine hydrochloride 1 percent cutaneous solution for the treatment of tinea pedis in consumers 18 and older, and a combination pack of 2 mg nicotine gum and nicotine patches that release 15 mg over 16 hours for smoking cessation. Finally, the agency doubles the maximum pack size of the allergy relief medicine loratadine 10 mg available for general sale from seven tablets to 14 tablets
You may also be interested in...
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.