Cenestin (synthetic conjugated estrogens, A)

3/24/1999

NDA 20-992

Duramed Pharmaceuticals, Inc.
Attention: Mr. John R. Rapoza, M.S., R. Ph.
Vice President, Regulatory Affairs
5040 Lester Road
Cincinnati, OH 45213

Dear Mr. Rapoza:

Please refer to your new drug application (NDA) dated March 27, 1998, received March 30, 1998, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Cenestin (synthetic conjugated estrogens, A) Tablets 0.625 mg and 0.9 mg.

We acknowledge receipt of your submissions dated April 6, May 7 and 27, June 19, September 22,

October 30 (2), November 20, December 8, 9 and 15, 1998; January 20, February 2, 4 and 10 and March 1, 4, 15, 17, 19, 22 and 23, 1999. The User Fee goal date for this application is March 30, 1999.

This new drug application provides for the use of Cenestin (synthetic conjugated estrogens, A) Tablets for use in the treatment of moderate-to-severe vasomotor symptoms associated with the menopause.

We have completed the review of this application, as amended, and have concluded that adequate information has been presented to demonstrate that this drug product is safe and effective for use as recommended in the agreed upon labeling text. Accordingly, the application is approved for the 0.625 mg and 0.9 mg tablets only, effective on the date of this letter. Please note that the dosing regimen allows for a range of doses including 0.625 mg through 2 X 0.625 mg.

In order to approve a 0.3 mg strength of Cenestin for this indication, a placebo-controlled study must be performed in a population of women with moderate-to-severe vasomotor symptoms associated with the menopause with adequate numbers of subjects randomized to the 0.3 mg strength to demonstrate the safety and effectiveness of this dose.

The final printed labeling (FPL) must be identical to the submitted draft labeling (package insert and patient package insert submitted March 23, 1999, immediate container and carton labels submitted March 15, 1999). Marketing the product with FPL that is not identical to the approved labeling text may render the product misbranded and an unapproved new drug.

Please submit 20 copies of the FPL as soon as it is available, in no case 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, this submission should be designated "FPL for approved NDA 20-992." Approval of this submission by FDA is not required before the labeling is used.

Validation of the regulatory methods has not been completed. At the present time, it is the policy of the Center not to withhold approval because the methods are being validated. Nevertheless, we expect your continued cooperation to resolve any problems that may be identified.

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:

 

Division of Drug Marketing, Advertising and Communications, HFD-40
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 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, contact Diane Moore, Regulatory Project Manager, at (301) 827-4260.

Sincerely,

Lisa D. Rarick, M.D.
Director Division of Reproductive and Urologic Drug Products
Office of Drug Evaluation II
Center for Drug Evaluation and Research

 


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