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

Astellas gets fifth action letter on modified-release tacrolimus

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Astellas Pharma receives another "approvable" letter for its once-daily formulation of its immunosuppressant Prograf (tacroliumus), dashing hopes of approval before a substance patent for the twice-daily formulation expired April 8. Prograf MR is under review for prophylaxis of organ rejection in both kidney and liver transplant patients. The Japanese firm received the second approvable letter for the liver transplant indication April 30; the kidney transplant indication got its second approvable letter in March. A heart transplant indication was deemed "not approvable" in January 2007. Astellas said it is "examining the future strategy" and working closely with FDA to better understand the issues raised. More time needed for Entereg review: After a three-month delay pushed back the user fee date for GlaxoSmithKline/Adolor's Entereg (alvimopan), FDA will not meet the scheduled May 10 action date, Adolor announces. After the Gastrointestinal Drugs Advisory Committee called the risk management plan inadequate in January, the firms submitted a new program in February. Entereg, indicated for postoperative ileus, has received two "approvable" letters since the NDA submission in 2004 (1Pharmaceutical Approvals Monthly November 2006, In Brief)

You may also be interested in...



GSK/Adolor Entereg approvable again

GlaxoSmithKline and Adolor plan to continue development of Entereg (alvimopan) after the NDA for management of post-operative ileus was deemed "approvable" a second time, the companies said Nov. 6. FDA noted a potential increased risk of cardiovascular events and requested additional 12-month safety data from GSK's ongoing Phase III safety study (76905/014) in opioid-induced bowel dysfunction in chronic cancer pain patients, as well as a risk management plan. The first approvable letter, issued in July 2005, requested additional efficacy data in patients following bowel resection surgery (1Pharmaceutical Approvals Monthly February 2006, p. 9). The response to the first approvable letter was submitted in May 2006; a response to the second letter appears unlikely before the second quarter of 2007, when final data from the 014 study is expected...

Hikma And Civica Ship Eight Essential Injectables

Hikma and Civica Rx have announced the launch of a first wave of eight essential injectable medicines, including heparin, as part of a deal struck between the two firms earlier this year.

AstraZeneca's Calquence Steps Up in First-Line CLL

A PFS benefit and favorable tolerability profile associated with AstraZeneca’s BTK inhibitor acalabrutinib used first-line in CLL, when given alone or combined with obinutuzumab, may serve it well against entrenched competitors and BTK inhibitors in clinical development.

Topics

UsernamePublicRestriction

Register

PS003827

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