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

Teva Leads Generic Rivals In First-To-File ANDAs By A Long Shot

Executive Summary

Teva has submitted 13 ANDAs with first-to-file opportunities to FDA this year, while rivals Mylan, Endo, Sandoz and Indian firm Hetero each have filed two ANDAs with FTFs, according to public data released by the agency and further analyzed by Teva.

You may also be interested in...



Meet The New Teva: 8% Global Generics Share, 300 ANDAs, 1,500 Launches

The world’s generic drug leader has cemented its leadership position for the foreseeable future with the acquisition of Allergan’s generics business. Management outlined how it plans to grow the combined business by taking advantage of its size during an investor briefing.

GDUFA II Will Include Small Business Relief, Priority ANDA Reviews

Generics industry and FDA have resolved remaining issues regarding financing of user fee program.

Mylan Sees A Difference In Having Generic Drug User Fees

FDA is pushing forward with its review of Mylan’s ANDA for generic Advair, according to the company, which is gaining confidence that the application could receive a first round approval. The experience for that application, which has a generic drug user fee, is a clear contrast to the firm's experience with its pre-GDUFA Copaxone filing.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL1134025

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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