FINDING OF NO SIGNIFICANT
IMPACT
NDA 20-3458
WELBUTRIN
(Bupropion hydrochloride)
Sustained Release Tablets
The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impact of their actions. FDA is required under NEPA to consider the environmental impact of approving certain drug products applications as an integral part of its regulatory process.
The
Food and Drug Administration, Center for Drug Evaluation and Research has
carefully considered the potential environmental impact of this action and has
concluded that this action will not have a significant effect on the quality of
the human environment and that an environmental impact statement therefore will
not be prepared.
In
support of their new drug application for WELLBUTRIN Sustained Release
Tablets, Burroughs Wellcome Co. has conducted a number of environmental
studies and prepared an environmental assessment in accordance with 21 CFR
15.31a(a) (attached) which evaluates the potential environmental impacts of the
manufacture, use and disposal of the product.
Bupropion
hydrochloride is a synthetic drug which is administered orally in the treatment
of depression. The drug substance and
drug product will be manufactured and packaged by Burroughs Wellcome Co.,
Greenville, NC. The finished drug
product will be used in hospitals, clinics and homes.
Bupropion
hydrochloride may enter the environment from excretion by patients, as
emissions from manufacturing sites or from disposal of pharmaceutical
wastes. Chemical and physical test
results indicate that the majority of the drug substance will be restricted to
the aquatic environment. Data indicate
that the material has the potential to rapidly photodegrade and will not
persist in the environment.
The
toxicity of the material to microorganisms was characterized and no inhibitory
effects are anticipated at the expected environmental concentrations.
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