Appendix A-43 Petition to Request a Change from a Listed Drug

• Author: Kenneth Dorsney
• Pages: 881-883

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

Room 1-23

12420 Parklawn Drive

Rockville, MD 20857

PETITION FILED BY:

[Name]

[City], [State] [Zip Code]

PROPOSED PRODUCTS:

Oral dosage forms containing __ mg [actdva dngmaddano ]

* * * * *

Introduction

The undersigned submits this petition under provisions of Section 505(j)(2)(C) of

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 [actdva dngmaddanon and dinaga ] is

suitable for evaluation under an ANDA.

Statement of Grounds

Pain of [dabdna pmiblem] remains a substantial problem for many patients.

Multimodal analgesic combinations, such as [Combination 1] and [Combination 2],

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A-43

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