RAPS

Mylan and Novartis to FDA: Where are the Suffixes?

Mylan and Novartis are taking issue with the fact that the US Food and Drug Administration (FDA) has yet to begin issuing random suffixes for biologics’ names and so far has only used suffixes for ...
JD Supra

What's in a Name? A Four-Letter Suffix to Be FDA Compliant

Most drugs on the market today are small-molecule compounds with active pharmaceutical ingredients that can be duplicated to create “generic” drugs. It is impossible, however, to create an exact ...
RAPS

FDA Begins Adding Suffixes to Newly Approved Biologics' Names

The US Food and Drug Administration (FDA) this week began adding four-letter meaningless suffixes at the end of newly approved biologics' nonproprietary names, signaling a shift in policy from only ...
JD Supra

FDA Issues Final Guidance Requiring Meaningless Suffixes for Biosimilar Names

Despite nearly universal opposition from both biosimilar makers and innovator companies, FDA has issued final guidance adopting its controversial August 2015 proposal for naming biologics. Under the ...
Reuters

FDA proposes adding suffixes to distinguish biosimilar drug names

WASHINGTON (Reuters) - The U.S. Food and Drug Administration proposed on Thursday identifying cheaper versions of biologic drugs with a suffix to distinguish them from their more expensive, branded ...