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

Janssen Sporanox

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Itraconazole injection and oral solution gains new indication May 9 for empiric therapy in febrile neutropenic patients with suspected fungal infections. FDA issued a public health advisory May 9 advising of hepatotoxicity associated with Sporanox capsules and Novartis' Lamisil (terbinafine) tablets and of "a small but real risk of developing congestive heart failure" with Sporanox. Labeling for both products was revised to strengthen the discussion on hepatotoxicity. A revised boxed warning for Sporanox warns against use of the product in patients with cardiac dysfunction and adds contraindications against administration with dofetilide (Pfizer's antiarrythmic Tikosyn) and pimozide (Gate's antipsychotic Orap)

You may also be interested in...



Colgate Was Drawn To Hello Products’ Youthful Lifestyle Branding, And Now It Has A CBD Line

Successfully acquired by Colgate-Palmolive on 31 January, Hello quickly made a statement with the launch of a CBD oral-care range and its first go at lip care, CBD Vegan Lip Balm. Available exclusively through Ulta Beauty, the CBD products have the potential to score well with younger consumers interested in natural ingredients, eco-friendly packaging and, of course, cannabis-based innovations.

Bluebird Expects Three Filings In 2020, But US Zynteglo Submission Pushed Back

A BLA filing for Zynteglo in beta-thalassemia is expected in the second half of 2020 instead of the first half, but the first commercial patient in the EU will be treated in the first half of this year.

Balancing Act: China Approves Antiviral For Coronavirus While Promoting Traditional Medicines

Amid the ongoing spread of the coronavirus outbreak, China turns to novel and repurposed antiviral drugs but also courts traditional medicines to ease public fear over the largely unknown threat.

Topics

UsernamePublicRestriction

Register

PS001510

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