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 Product Approval Information - Licensing Action

Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

April 12, 2002

Submission Tracking No. (STN): BL 103000/5000

Mr. Peter A. Kresel
Allergan, Inc.
2525 Dupont Drive
P.O. Box 195
Irvine, CA 92713-9534

Dear Mr. Kresel:

The Supplement to your License Application, for Botulinum Toxin Type A to include the indication of treatment of glabellar lines, has been approved.

Under this approval, Botulinum Toxin Type A will be marketed and labeled for this indication as BOTOX COSMETIC.

Botulinum Toxin Type A (BOTOX) is currently licensed for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia and the treatment of strabismus and blepharospasm associated with dystonia. Under this approval, Botulinum Toxin Type A (BOTOX COSMETIC) may be used for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients < 65 years of age.

Under this approval, BOTOX COSMETIC shall be supplied, in vials, as a lyophilized formulation at a dose of 100 U per vial and the expiration dating period shall be 24 months when stored at -5°C to -20°C.

We acknowledge your March 11, 2002, submission of the final report for reproductive toxicity testing studies to BB IND XXXX. This submission is currently under review and we reserve the right to comment further on the contents of that submission and request further revisions to the labeling for BOTOX COSMETIC as warranted.

We acknowledge your commitment of March 26, 2002, to review the post-marketing adverse event surveillance data after one year of commercial distribution and propose revised labeling as warranted.

We have reviewed your request for a waiver from the requirement to assess the safety and effectiveness of the product in pediatric populations. Please be advised that a waiver for this application is granted under 21 CFR 601.27.

This information will be placed in your License Application File for this product.

Changes in the manufacturing process, manufacturing facility, product testing, packaging or labeling for Botulinum Toxin Type A (BOTOX and BOTOX COSMETIC) may require the submission of a supplement to your biologics license application for review and approval prior to implementation.

It is required that adverse experience reports be submitted in accordance with the adverse events reporting requirements for licensed biological products (21 CFR 600.80) and that distribution reports be submitted as described (21 CFR 600.81). All adverse experience reports should be prominently identified according to 21 CFR 600.80 and be submitted to the Center for Biologics Evaluation and Research, HFM-210, Food and Drug Administration, 1401 Rockville Pike, MD 28052-1448.

It is required that reports of errors and accidents in manufacture be submitted in accordance with the error and accident reporting requirements for licensed biological products (21 CFR 600.14). All error and accident reports should be identified promptly according to 21 CFR 600.14 and submitted to the Director, Office of Compliance, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Rockville, MD 20852-1448.

Please submit final printed labeling at the time of use and include implementation information on FDA Form 2567. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels). In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2567 or Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. Final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by a FDA Form 2567 or Form 2253.

All promotional claims must be consistent with and not contrary to approved labeling. No comparative promotional claim or claim or superiority over other similar products should be made unless data to support such claims are submitted to and approved by the Center for Biologics Evaluation and Research.

Sincerely yours,

--- signature ---

Karen L. Goldenthal, M.D.
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Last Updated: 4/14/2002


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Date created: September 25, 2003

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