DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`Public Health Service
`
`Food and Drug Administration
`Rockville, MD 20857
`
`NDA 16-033/S-011
`
`GlaxoSmithKline
`Attention: Willa Phyall
`Associate Director
`U.S. Regulatory Affairs
`One Franklin Plaza
`200 N 16th Street
`Philadelphia, PA 19102
`
`Dear Ms. Phyall:
`
`Please refer to your supplemental new drug application dated April 11, 1990, received April 17, 1990,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Vontrol Tablets.
`
`This "Changes Being Effected" supplemental new drug application provides for the revisions to the
`Dosage and Administration, “Children –For Nausea and Vomiting” section as follows:
`
`• The sentence “Unit doses in children are best calculated by body weight: usually 0.4mg/lb” has
`been deleted from the first paragraph.
`In the second paragraph, the word “dose” has been replaced with “dosage”.
`In the note, the word “dosage” has been replaced with “dose”.
`
`•
`•
`
`We have completed the review of this supplemental application and have concluded that adequate
`information has been presented to demonstrate that the drug product is safe and effective for use as
`recommended in the agreed upon labeling text. Accordingly, this supplemental application is
`approved effective on the date of this letter.
`
`The final printed labeling (FPL) must be identical to the submitted draft labeling April 10, 1990.
`
`Please submit the copies of final printed labeling (FPL) electronically to each application according to
`the guidance for industry titled Providing Regulatory Submissions in Electronic Format - NDA
`(January 1999). Alternatively, you may submit 20 paper copies of the FPL as soon as it is available
`but no more than 30 days after it is printed. Please individually mount ten of the copies on heavy-
`weight paper or similar material. For administrative purposes, these submissions should be designated
`"FPL for approved supplement NDA 16-033/S-011". Approval of this submission by FDA is not
`required before the labeling is used.
`
`In addition, please submit three copies of the introductory promotional materials that you propose to
`use for this product. All proposed materials should be submitted in draft or mock-up form, not final
`print. Please submit one copy to this Division and two copies of both the promotional materials and
`the package insert directly to:
`
`

`

`NDA 16-033
`
`page 2
`
`Division of Drug Marketing, Advertising, and Communications, HFD-42
`Food and Drug Administration
`5600 Fishers Lane
`Rockville, Maryland 20857
`
`If a letter communicating important information about this drug product (i.e., a "Dear Health Care
`Professional" letter) is issued to physicians and others responsible for patient care, we request that you
`submit a copy of the letter to this NDA and a copy to the following address:
`
`MEDWATCH, HF-2
`FDA
`5600 Fishers Lane
`Rockville, MD 20857
`
`Please submit one market package of the drug product when it is available.
`
`We remind you that you must comply with the requirements for an approved NDA set forth under
`21 CFR 314.80 and 314.81.
`
`If you have any questions, please call Melaine Shin, R.Ph., Regulatory Management Officer, at (301)
`594-5793.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Russell Katz, M.D.
`Director
`Division of Neuropharmacological Drug Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`

`

`--------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`--------------------------------------------------------------------------------------------------------
` /s/
`---------------------
`Russell Katz
`8/6/01 10:23:18 AM
`
`
`
`