FDA Updates Salt Drug Naming Guidance

June 22, 2015

The FDA issued final guidance last week formally adopting the U.S. Pharmacopeia’s strict naming rules for drug containing salt-based active ingredients.

Under the policy, new drugs containing a salt should use the active moiety in the name and include its strength in the label as well, not name of the salt.

Companies may use the name of the salt in the name if any of the following conditions are met:

  • The active ingredient is a relatively simple salt and administration is therapeutically important;
  • Evidence demonstrates the salt affects absorption, distribution, metabolism and/or excretion in a manner that could influence a doctor’s selection;
  • Clinically significant amounts of cations (sodium, potassium, magnesium or calcium) accompany the active ingredient; or
  • There are significant evidence-based safety concerns that the counter-ion part of the salt could cause acid-based disturbances, organ damage or hypersensitivity reactions.

While it doesn’t anticipate changing existing names of drugs, the FDA says it could do so if necessary for safety.

The guidance finalizes draft guidance issued in December 2013, seven months after the USP Salt Policy was implemented in May 2013. Read it at www.fdanews.com/06-17-15-salt.pdf. — John Bechtel