Approval letter

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993
NDA 021098/S-017 SUPPLEMENT
APPROVAL
Bayer HealthCare Pharmaceuticals Inc. Attention: Nancy Velez Associate Director, Global Regulatory Affairs P.O. Box 1000 Montville, NJ 07045-1000 Please refer to your supplemental new drug application dated and received April 1, 2010, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for YASMIN® (drospirenone 3 mg/ethinyl estradiol 0.03 mg) Tablets. We also acknowledge receipt of your submissions dated April 5 and 7, 2010. This “Prior Approval” supplemental new drug application provides for the addition of new information in the Thromboembolism subsection of the Thromboembolic Disorders and other Vascular Problems subsection of WARNINGS. The new information concerns the relative risks of thromboembolism in women using YASMIN compared to those in women using combination oral contraceptives containing other progestins. We have completed our review of this application. It is approved, effective on the date of this letter, for use as recommended in the enclosed, agreed–upon labeling text for the Physician and Patient Package Inserts. CONTENT OF LABELING
Please resubmit the enclosed content of labeling in SPL format as soon as possible, but no later
than 14 days from the date of this letter. For administrative purposes, please designate this
submission, "SPL for approved NDA 021098/S-017."
PROMOTIONAL MATERIALS
All promotional materials for your drug product that include representations about your drug product must be promptly revised to make it consistent with the labeling changes approved in this supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions to your promotional materials should include prominent disclosure of the important new safety information that appears in the revised package labeling. Within 7 days of receipt of this letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4) to the following address or by facsimile at 301-847-8444: Food and Drug Administration Center for Drug Evaluation and Research Division of Drug Marketing, Advertising, and Communications 5901-B Ammendale Road Beltsville, MD 20705-1266 In addition, as required under 21 CFR 314.81(b)(3)(i), you must submit your updated final promotional materials, and the package insert(s), at the time of initial dissemination or publication, accompanied by a Form FDA-2253, directly to the above address. For instruction on completing the Form FDA 2253, see page 2 of the Form. For more information about submission of promotional materials to the Division of Drug Marketing, Advertising, and Communications (DDMAC), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm. LETTERS TO HEALTH CARE PROFESSIONALS
If you issue a letter communicating important safety related information about this drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit an electronic copy of the letter to both this NDA and to the following address: REPORTING REQUIREMENTS
We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80 and 314.81). If you have any questions, please call Pamela Lucarelli, Regulatory Health Project Manager, at (301) 796-3961. {See appended electronic signature page} Scott Monroe, M.D. Director Division of Reproductive and Urologic Products Office of Drug Evaluation III 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.
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/s/
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