`RESEARCH
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`APPLICATION NUMBER:
`201281Orig1s000
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`ENVIRONMENTAL ASSESSMENT
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`138
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`Section 1.14.1.1 in the labeling section of the electronic submission indicates that
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`there are both draft carton and container labels in the submission. However, only
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`container (bottle) labels were provided. The firm should explain this discrepancy
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`and provide the carton labels, if appropriate.
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`Comments to be Communicated to the Applicant
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`Section 1.14.1.1 in the labeling section of the electronic submission indicates that
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`there are both draft carton and container labels in the submission. However, only
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`container ( bottle) labels were provided. You should explain this discrepancy and
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`provide the carton labels, if appropriate.
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`Since the product needs to be protected from high humidity, your immediate
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`container labels should contain a brief statement about the need to keep the
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`desiccant packet in the bottle after opening.
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`Structure Product Labeling (SPL)
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`Structure Product Labeling, at the end of the package insert will be reviewed at a
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`later date.
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`ENVIRONMENTAL ASSESSMENT
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`The firm requests a Categorical Exclusion (waiver) from the preparation of an
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`Environmental Assessment under 21CFR§25.31(a) and (b), since the estimated
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`concentration of linagliptin at the point of entry into the aquatic environment will
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`be below 1 part per billion. The claim for a Categorical Exclusion for metformin
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`HCl is based on 21CFR§25.31(a) because they claim approval would not
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`increase the use of this previously approved drug since it is expected that those
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`patients switching to linagliptin/metformin HCl tablets will no longer use other
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`previously approve products containing metformin HCI.
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`Evaluation:
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`The request for the waiver is acceptable
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`Reference ID: 2961261
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`Reference ID: 3083109
`Reference ID: 3083109
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