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


Dr. Reddy’s Gets FDA Advertising Letter, But Its Response Is Far From Generic

This article was originally published in The Pink Sheet Daily

Executive Summary

Despite changes to the website, the boxed warning about the risk of epidural or spinal hematomas for patients taking generic fondaparinux still receives little emphasis on a Dr. Reddy’s promotional page.

You may also be interested in...

MS Product Ads Kept On Short (Study) Leash As Avonex Draws FDA Letter

FDA says a chart on Biogen Indec’s website implies Avonex is superior to Copaxone, Rebif, Betaseron and Extavia; the notice of violation was issued the same day FDA sent a warning letter to Teva citing its Copaxone promos.

FDA Warning Letters Hit Inadequate Investigations and QC Failings

In recent warning letters, FDA continued to hammer manufacturers for inadequate investigation of out-of-specification results and lax oversight of manufacturing operations by quality control units.

FDA Cites Imaging Drug Web Sites, Draws "Respectful" Disagreement

Bracco Diagnostics took down a promotional Web site in response to an untitled letter from DDMAC but disagrees that it hyped a study. GE Healthcare's Visipaque is cited in a separate letter.


Related Companies




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