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EA
Review #1, NDA 20-358 |
Page 14 |
DRAFT DEFICIENCY LETTER
1. Regarding Section 4, description of the proposed action:
a.
Requested
.Approval: The description of the
request should mention the NDA number.
b.
Need
for Action: The added benefit of
sustained-release tablets over the presently marketed immediate-release tablets
should be stated.
c.
Production
Locations:
i.
Proprietary
Intermediates: It should be confirmed
that none of the input materials are proprietary intermediates that are manufactured
at another location. If proprietary
intermediates are used, information about their manufacture must be provided.
ii.
The
exact addresses for the facilities used in production of drug substance and
drug product should be provided.
iii.
Disposal
Locations: The license number of the
off-site incineration facility used by The Wellcome Foundation Limited, and the
dates of expiration for the licenses of the incineration facility and the
landfill site, should be given. In
addition, the application should state that disposition of drug product in a
landfill is appropriate based on the toxicity of the drug substance.
2. Regarding Section 7, Fate of Emitted Substances in the Environment:
a.
It
should be confirmed that the unidentified polar metabolites are more polar than
the parent compound and contain the same backbone chemical structure.
b.
A
literature reference to the publication of the waste solubility of the drug
substances should be provided, together with any supportive data obtained or
appearing since 1976.
c.
A
reference for the method used to measure hydrolysis rate should be provided,
together with a discussion of
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