Pink Sheet is part of Pharma Intelligence UK Limited
This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.
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
This article was originally published in Pharmaceutical Approvals Monthly
Connetics' acne treatment Velac (clindamycin/tretinoin) is "not approvable" at FDA due to dermal carcinogenicity concerns, the company says June 13. FDA issued a "not approvable" letter on June 10, roughly two weeks ahead of a June 25 action date. Connetics believes the issue can be resolved without a new preclinical study...
| Table |
|---|
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.
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.
