December 2021

Subject: Change in recommended storage conditions for CombiPatch® (estradiol/ norethindrone acetate transdermal system)

Dear Health Care Provider,

Noven Pharmaceuticals, Inc. would like to inform healthcare professionals of the change in storage conditions for CombiPatch® (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg/day and 0.05/0.25 mg/day, as approved by the U.S Food and Drug Administration (FDA). The new storage condition requires to only “store CombiPatch in the refrigerator at 2°C to 8°C (36°F to 46°)”. Previous CombiPatch storage conditions allowed for the product to be stored as follows: “Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F). After dispensing to the patient, CombiPatch can be stored at room temperature between 20°C to 25°C (66°F to 77°F) for up to 6 months”.

The change in the storage condition for CombiPatch from up to 6 months at room temperature between 20°C to 25°C (66°F to 77°F) to fully refrigerated between 2°C to 8°C (36°F to 46°F), is not due to a product change. Recent analyses of test results showed that storage of CombiPatch in refrigerated conditions of 2°C to 8°C (36°F to 46°F) lead to improvement of product adhesion.

Starting December 2021, healthcare professionals are advised to inform their patients of the revised storage conditions and to ensure that the product is stored according to the new instructions: CombiPatch should be kept in refrigerated storage conditions (2°C to 8°C (36°F to 46°)) in its sealed foil pouch until the patient is ready to apply the transdermal system.

Please be advised that starting August 2022, patients will see changes on the outer packaging of CombiPatch reflecting these storage condition changes. Until then, we advise you to proactively inform any patient receiving CombiPatch of its new storage conditions.

Prescriber Action:

Counsel all patients about the risks and benefits of CombiPatch, including:

• The new storage requirements to ensure optimal adhesion of the product.

• Patients should store all sealed CombiPatch in the refrigerator (2°C to 8°C (36°F to 46°F)) until they are ready to apply the transdermal system. Allow the transdermal system to reach room temperature before application.

  
  

  Note: All commercially available CombiPatch stored at previous storage recommendations are still safe and effective for use and, can continue to be used by patients.

  
  

  Please ensure your staff and any provider in your institution who may be involved in the handling, storage and dispensing of CombiPatch, receives a copy of this letter and specifically reviews the updated storage conditions.

  
  

  Reporting Adverse Events

  Noven encourages the reporting of adverse events expeditiously. To report adverse events, product quality complaints or to request medical information related to CombiPatch please contact Noven Medical Information at (800) 455-8070 (9 a.m- 5 p.m EST, Mon-Fri).

  
  

  Adverse events or quality problems experienced with the use of this product may also be reported to the FDA MedWatch Adverse Event Reporting program either online, by regular mail, telephone, or fax.

  
  

• Online: www.fda.gov/medwatch/report.htm

• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:

• www.fda.gov/MedWatch/getforms.htm. Mail to: MedWatch, 5600 Fishers Lane, Rockville, MD 20857

• Telephone: 1-800-332-1088

• Fax: 1-800-FDA-0178

This letter is not intended as a complete description of the benefits and risks related to the use of CombiPatch. Please refer to the enclosed full prescribing information including patient information. For additional information, please call Noven at 1-800-455-8070 or visit www.combipatch.com.

We will continue to work diligently to provide a consistent supply of CombiPatch. We appreciate your assistance in this matter and apologize for any inconvenience.

Sincerely,

Joel S. Lippman, MD COO & CMO