Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Australia switches chloramphenicol eye drops

This article was originally published in The Tan Sheet

Executive Summary

Australia moves chloramphenicol-containing eye drops to nonprescription distribution by pharmacists, harmonizing the country's regulation with New Zealand's. The National Drugs and Poisons Schedule Committee in October said that other nonprescription products are indicated for mild cases of bacterial conjunctivitis, but it is "sensible to allow pharmacists to supply cholramphenicol for the treatment of more severe, uncomplicated cases." Australia and New Zealand are harmonizing requirements for therapeutic products and establishing a joint regulatory scheme under the Trans-Tasman Mutual Recognition Arrangement (1"The Tan Sheet" Feb. 2, 2009). Chloramphenicol-containing eye drops remain Rx in the U.S

You may also be interested in...



Therapeutic Product Regulatory Reforms Considered Down Under

Australia's Therapeutic Goods Association plans to implement a number of regulations to update and streamline the existing framework for over-the-counter and prescription drugs as well as medical devices

GSK Leaving Pennsylvania Emergen-C Plant, Adding Voltaren To US OTC Line

UK pharma announced that in 2021 it will close its manufacturing facility in Carlisle, PA, where around 260 people are employed making the Emergen-C line. It will move the manufacturing to its Guayama, PR, facility.

Priority Review Voucher Programs Poised For US Legislative Attention In 2020

Unless reauthorized by Congress, the rare pediatric disease program will begin to expire in September; renewal could bring bigger changes across the three PRV programs, including an FDA-requested clarification of biologic products eligible for vouchers and reforms suggested by sponsors and other stakeholders in a recent GAO report.


Topics

UsernamePublicRestriction

Register

PS103606

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel