Drugs

More Info Sought on Salt Guidance

AbbVie says it would like more information from FDA on how it plans to enforce the United States Pharmacopeia (USP) salt policy for those products in development between 5/1/13 when the policy became effective and the final issuance of an FDA draft guidance on naming of drug products containing salt drug substances. The AbbVie comment letter raises additional questions for which it seeks more information.

The American Society of Health-System Pharmacists (ASHP) says it has long expressed concern about the change in policy for drug nomenclature established by USP in 2006. It says the society’s Council on Therapeutics found that USP had not demonstrated through adequate stakeholder input or data that the possible benefits of dropping the salt name from the name of the official monograph clearly outweighed the potential risks of inappropriate dosing; problems with solubility, stability, and compatibility; and the deleterious effect on a patient’s condition that could result from camouflaging the salt. ASHP says it is encouraged that FDA outlines an exception process by which the name of the salt could be retained under a number of specific conditions. It recommends that the agency describe further how manufacturers should interpret the exemption conditions in deciding whether to request an exemption to ensure patient safety. It also calls on FDA to expand the draft guidance to include further discussion of interpretation for industry of the exemptions as manufacturers will be responsible for requesting such exemptions.

In its response, AstraZeneca said that overall the guidance is logical and the clarifications provided are considered helpful. It also suggested that alignment with the European position on the determination of product strength is welcomed.

Finally, Bristol-Myers Squibb says that FDA should clarify the use of prefixes to denote stoichiometry as it pertains to the draft. It recommends including an additional example to address cases in which salt stoichiometry is critical to establishing active substance labeling.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome