Generics Bulletin 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

Teligent Surprised By Orphan Generic Setback

FDA Wants More Information On Complex Generic

Executive Summary

US niche generics specialist Teligent has expressed surprise at a complete response letter issued by the FDA over an application for a generic of an orphan drug.

You may also be interested in...



Teligent Slammed By FDA Warning Letter

Rather than blame employees for ignoring 397 product complaints, Teligent should have fixed complaint handling system, US FDA warning letter says.

Pressure Mounts For German Tender Reforms

Germany’s off-patent industry association, Pro Generika, is finding ample support for its position that by awarding tender contracts to exclusive suppliers, health insurance funds are contributing to drug shortages in the country.

Teva Leapfrogs Mylan And Sandoz On Linaclotide

A patent-litigation settlement that Teva has reached with Ironwood and Allergan over Linzess will allow the Israeli firm to enter the US market with the linaclotide-based constipation treatment ahead of major rivals Mylan, Sandoz, Sun Pharma and Aurobindo.

Topics

Related Companies

UsernamePublicRestriction

Register

GB149487

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