Sun Pharmaceutical Industries Limited: nilotinib

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response to your application.

FDA may determine that a CGMP reinspection and/or additional pre-approval inspection (PAI) is needed to confirm satisfactory resolution of inspection deficiencies before this application can be approved.

1. During recent inspections of the Sun Pharmaceutical Industries Limited, FEI:

3. Provide justification that the dose banding instructions in Section 2 of the prescribing information, which would result in an inherent approximation of the recommended dose, do not affect the safety and efficacy of the drug in its conditions of uses.

1. During a recent inspection of the Sun Pharmaceutical Industries Ltd manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility.

Satisfactory resolution of these deficiencies is required before this application may be approved.

We recommend the following comments be implemented prior to commencing the gemcitabine hydrochloride in sodium chloride injection summative human factors study.

Thus, your currently proposed labeling plan could be error prone.

You should consider incorporating a table in the Dosage and Administration section of the Prescribing Information that instructs the prescriber to round the dose.

10. We reserve additional comment on the proposed labeling until the application is otherwise adequate.