The policy will affect the way salt is expressed in the non-proprietary name, or non-brand name, of a new drug as of May 1, 2013.
Under the new policy, the name for most new drugs with salt will only include the active moiety for the name and strength of that drug product. The name and strength of the specific salt form will be provided elsewhere on the label.
If we applied the policy today using a current drug as an example, this is how the policy would impact the name. If Morphine Sulfate ER tablets were released after May 1, 2013, it would not have the salt, in this case the sulfate, in its name, and its specific salt form and strength would be noted elsewhere on its label. For this example, the name would become Morphine ER tablets. This new policy will be applied to new drugs as of May 1, 2013 and may possibly affect a few existing drugs.
An active moiety is the molecule or ion, excluding those appended portions of the molecule that cause the drug to be a salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule. The active moiety is responsible for the physiological or pharmacological action of the drug substance, without regard to the actual charged state of the molecule in vivo. For example, the active moiety of a hydrochloride salt of a base is the free base and not the protonated form of the base. The active moiety of a metal salt of an acid is the free acid.
Each mL contains:
New Drug..... 10 mg
(as New Drug Hydrochloride USP, 10.5 mg), edetate disodium 45 mg, methylparaben 0.8 mg and propylparaben 0.1 mg as preservatives, and anhydrous citric acid and/or sodium hydroxide, as necessary, to adjust pH.
Each mL contains:
New Drug..... 10 mg
(provided as New Drug Hydrochloride USP, 10.5 mg), edetate disodium 45 mg, methylparaben 0.8 mg and propylparaben 0.1 mg as preservatives, and anhydrous citric acid and/or sodium hydroxide, as necessary, to adjust pH.
Each mL contains:
New Drug..... 10 mg
(equivalent to New Drug Hydrochloride USP, 10.5 mg), edetate disodium 45 mg, methylparaben 0.8 mg and propylparaben 0.1 mg as preservatives, and anhydrous citric acid and/or sodium hydroxide, as necessary, to adjust pH.
Each mL contains:
New Drug Hydrochloride USP..... 10.5 mg
(equivalent to New Drug 10 mg),
edetate disodium 45 mg, methylparaben 0.8 mg and propylparaben 0.1 mg as preservatives, and anhydrous citric acid and/or sodium hydroxide, as necessary, to adjust pH.
Each mL contains:
New Drug..... 10 mg
(as New Drug Hydrochloride USP, 10.5 mg), edetate disodium 45 mg, methylparaben 0.8 mg and propylparaben 0.1 mg as preservatives, and anhydrous citric acid and/or sodium hydroxide, as necessary, to adjust pH.
Each mL contains:
New Drug..... 10 mg
(provided as New Drug Hydrochloride USP, 10.5 mg), edetate disodium 45 mg, methylparaben 0.8 mg and propylparaben 0.1 mg as preservatives, and anhydrous citric acid and/or sodium hydroxide, as necessary, to adjust pH.
Each mL contains:
New Drug..... 10 mg
(equivalent to New Drug Hydrochloride USP, 10.5 mg), edetate disodium 45 mg, methylparaben 0.8 mg and propylparaben 0.1 mg as preservatives, and anhydrous citric acid and/or sodium hydroxide, as necessary, to adjust pH.
Each mL contains:
New Drug Hydrochloride USP..... 10.5 mg
(equivalent to New Drug 10 mg),
edetate disodium 45 mg, methylparaben 0.8 mg and propylparaben 0.1 mg as preservatives, and anhydrous citric acid and/or sodium hydroxide, as necessary, to adjust pH.
