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

Schering betamethasone withdrawals

Executive Summary

FDA determines Jan. 11 that Schering-Plough's Celestone Soluspan (betamethasone sodium phosphate/betamethasone acetate) and Celestone (betamethasone sodium phosphate) were not withdrawn due to safety and efficacy issues; the two betamethasone products were withdrawn due to manufacturing issues, agency says. The determination allows the agency to approve abbreviated NDAs for betamethasone sodium phosphate/betamethasone acetate and for betamethasone sodium phosphate injections if all other regulatory requirements are met. In the interim, Celestone Soluspan will only be available in "certain instances of medical necessity only," FDA says...

You may also be interested in...



Not Too Late? German Industry Presses For EU MRA With Post-Brexit UK

BVMed says the EU and the UK should set up a system of mutual recognition of medical device regulation to kick in when the UK’s EU exit transition period ends on 31 December. 

ESMO: Daiichi's HER3-Targeting ADC Shows Promise, Particularly In Resistant Tumors

HER3 may be a new target for anticancer antibody-drug conjugates; clinical investigators posted promising early stage clinical results with Daiichi Sankyo’s HER3 targeting antibody-drug conjugate, patritumab deruxtecan, at the recent ESMO virtual meeting.

Stockwatch: Can Gilead Wave Its Wand Over Antibody-Drug Conjugates?

After a slow start marked by product withdrawals and toxicity, recent deal-making activity has brought antibody-drug conjugates back from obscurity. But what has changed?

UsernamePublicRestriction

Register

ID1122310

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