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Chemistry Assessment Section

 

the drug substance.  The drug substance is described as a white crystalline solid that is highly soluble in water and has a bitter taste.  Bupropion hydrochloride is designated as (±)-1-(3-chlorophenyl)-2-[1,1-dimethylethy) amino]-1-propanone hydrochloride.  The molecular formulation for is C₁₃H₁₈ClNO·HCl and the molecular weight is 276.2.  A letter of authorization is provided on page 2 of volume 4.1.  There is no information pertaining to the synthesis of the drug substance outlined in this application.  The applicant intends to adopt the current USP (effective January 1, 2003) specifications for the drug substance[.]

 

The drug product, Wellbutrin XL^TM Tablets is an antidepressant designed for once a day administration.  The drug product, Wellbutrin XL^TM, is a [blacked out] tablet consisting of [blacked out].  Together, the coatings form a [blacked out] that is responsible for the release of the drug substance, bupropion hydrochloride.  All ingredients used in the manufacture of the drug product with the exception of [blacked out].  Black Ink are either USP or NF grade.  The applicant indicates that the drug product will be available in two dosages 150 mg and 300 mg and will be manufactured at the Biovail Lifesciences in Steinbach, CA.  The 150 mg tablets are creamy white to pale yellow round tablet imprinted with “Wellbutrin XL 150” in black ink on one side and plain on the other side.  The 300 mg tablets are creamy white to pale yellow round tablets imprinted with “Wellbutrin XL 300” in black in on one side and plain on the other side.  The tablets will be packaged in 7 count [blacked out] bottles for physician samples and 30 count [blacked out] for commercial distribution.  Both the 30 and 7 count bottles will be packaged with a [combination] [blacked out] and closed with a [blacked out] child resistant closure.

 

The applicant proposed the proprietary name Wellbutrin XL^TM Tablets for the drug product.  The Office of Post-Marketing Drug Risk Assessment (OPDRA) has not posed any objections to the use of this name.

 

 

 

B.  Description of How the Drug Product is Intended to be Used

Wellbutrin XL^TM is being developed for the treatment [of] major depressive disorder.  It’s [Its] extended release formulation is designed for patients that suffer from MDD.  The application has provided a confirmatory bioequivalence study comparing Wellbutrin XL^TM Tablets with the currently marketed Wellbutrin® Tablets.  The applicant indicates that administration should begin with the 150 mg dose and if that dose is well tolerated then the patient should increase to the 300 mg/day target dose.  The applicant further indicates that an increase to the maximum daily dose of 450 mg/day may be given as a single dose or divided dose.

 

The applicant has requested a [blacked out] expiry for the 150 and 300 mg tablets in the 7 and 30 bottles.  The applicant provided 6 months of accelerated (40°CC/75% RH) stability data together with 12 months of long term (30°C/60% RH) and intermediate (30°C/60% RH) stability data on six [blacked out] batches of the drug product in each of the proposed commercial packages.  The applicant updated the dissolution specification from the original submission.  

 

 

 

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