EA Review #1, NDA 20-358

Page 15

 

any significant deviations from the EATAD 3.09 of the FDA’s Environmental Assessment Technical Assistance Handbook.

 

d.       For the measurement of dissociation constant, a discussion of any significant deviation from EATAD 3.04 of the FDA’s Environmental Assessment Technical Assistance Handbook should be provided.

 

e.        A literature reference to the publication of the log Kow of the drug substance should be provided together with any supportive data obtained or appearing since 1976.

 

f.         For aqueous photodegradation:  The half-lives presented are experimental values in the presence of xenon arc lamp.  Considerably longer half-lives for aqueous photodegradation were obtained from calculations which normalized these results to flat bodies of water at various seasons and latitudes (see page 177).  Since many of these half-lives exceed the threshold of 5 days, the statement that the drug substance is subject to rapid photodegradation in aqueous media (page 14) is misleading.  Photodegradation cannot be considered a primary depletion mechanism unless the longer half-lives can be shown to be irrelevant to the locations or seasons where the substance may be released.

 

3.                    Regarding Section 8, Environmental Effects of Released Substances:

 

Search the literature and report available test data and slso [also] report any mammalian toxicity information.  A computerized structure activity relationship modeling program could be used to supplement the literature information.

 

 

 

 

 

 

Back a Page
Next Section - Attachments
Back to Wellbutrin SR® NDA Index Page
Back to Main Index