Petition to Request a Change from a Listed Drug

AuthorKenneth L. Dorsney
Pages881-883
Petition to Request a Change from a Listed Drug
PETITION TO REQUEST A CHANGE FROM A LISTED DRUG
[Date]
Dockets Management Branch
Food and Drug Administration
Department of Health and Human Services
[Name]
PROPOSED PRODUCTS:
Oral dosage forms containing __ mg [active ingredient]
* * * * *
Introduction
the Federal Food, Drug, and Cosmetic Act (“FFDCA”) as implemented by 21 CFR
§314.93 and according to Part §10.20 of the same title. The petitioner requests the
Commissioner of Food and Drugs to make a determination that the drug products
described hereinafter, with a slightly different strength than the listed drugs, are
suitable for marketing under an Abbreviated New Drug Application (“ANDA”)
because:
a) Investigations are not necessary to show the safety and effectiveness of
the proposed drugs or any of the active ingredients or the strength; and
b) There are no active ingredients which may not be adequately evaluated for
approval as safe and effective on the basis of the information to be submitted in an
abbreviated application.
The petitioner requests the Commissioner of Food and Drugs to make a determination
that a drug product containing a combination of [active ingredients and dosage] is
suitable for evaluation under an ANDA.
Pain of [define problem] remains a substantial problem for many patients.
Multimodal analgesic combinations, such as [Combination 1] and [Combination 2],
881
A-43
dor54588_24_app_663–914.indd 881 5/5/16 5:06 PM

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