Terms of Use

Welcome to the COMBIPATCH brand web site of Noven Therapeutics LLC (Noven, our, we or us). This web site is produced by Noven Therapeutics LLC. Please read these Terms of Use before viewing or using any portion of this web site.By accessing and using the web site, you acknowledge that you have read, understood, and accept all the Terms of Use and will be bound by them. If you do not agree to the Terms of Use, you may not access or otherwise use the web site.

 

The information provided on this site is for general information and educational purposes only and may not be used as an alternative to or supplement to healthcare. Nothing on this web site should be considered medical advice. Patients should not use the information contained herein for diagnosing a health or fitness problem or disease. Please consult with your healthcare professional about any medical questions you may have.

 

Noven Therapeutics LLC reserves the right, in its sole discretion, to change the Terms of Use at any time, as appropriate. Your continued use of the web site following such changes shall be deemed your acceptance of the changes.

 

his web site and its contents are intended to comply with the laws and regulations in the United States. The products and product information on this web site are intended only for residents of the United States and its territories who generally are 18 years of age or older. Information on Attention Deficit and Hyperactivity disorder and childhood epilepsy, for example, may be appropriate to help adolescents 13 years of age or older discuss these topics with their parent(s), caregiver(s), or healthcare professional(s).

 

The products discussed on this web site may not be available in all countries or may be available under different names, in different strengths or formulations. Noven Therapeutics LLC products should only be used or administered consistent with approved labeling and pursuant to your healthcare professional’s direction.

 

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Subject to any applicable terms and conditions set forth in our Privacy Policy, any communication or other material that you send to us through the internet or post on a Noven web site by electronic mail or otherwise, such as any questions, comments, suggestions or the like, is and will be deemed to be non-confidential and Noven shall have no obligation of any kind with respect to such information. Noven shall be free to use any ideas, concepts, know-how or techniques contained in such communication for any purpose whatsoever, including but not limited to, developing, manufacturing and marketing products. Reasonable efforts have been made to provide accurate and current information on this web site, but it is not comprehensive in scope. Noven Therapeutics LLC makes no representation as to the availability, accuracy or completeness of the content of this site.

 

THIS WEB SITE IS PROVIDED “AS IS” AND THE COMPANY MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT. THE COMPANY DOES NOT WARRANT THAT THE FUNCTIONS CONTAINED IN THE WEB SITE WILL BE UNINTERRUPTED OR ERROR FREE OR THAT THE WEB SITE OR THE SERVER THAT MAKES IT AVAILABLE ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS. SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OF IMPLIED WARRANTIES, SO PART OF THE ABOVE EXCLUSION MAY NOT APPLY TO YOU.

 

In no event and under no circumstances shall Noven Therapeutics LLC, its affiliates, and subsidiaries, and their respective officers, directors, employees, agents, representatives, information providers and licensors, and their respective heirs and assigns be liable for any direct, indirect, incidental, consequential, special exemplary, punitive or other damages, even if informed of the possibility of such damages, resulting from your access to, or inability to access, this site or from your reliance on any information on this site. Noven Therapeutics LLC shall not be liable for any damages or injury resulting from your access to, or inability to access, this site or from your reliance on any information on this site.

 

You agree that all access and use of this Web site and its content is at your own risk. You further agree that you will not upload, post, transmit, distribute or otherwise publish through the web site any materials that: 1) restrict or limit the ability of any other User to use this web site; 2) are unlawful, threatening, abusive, libelous, defamatory, obscene, pornographic, profane, or indecent; 3) constitute or encourage conduct that would be a criminal offense, give rise to civil liability, or otherwise violate the law; 4) violate, plagiarize, or infringe the rights of any third parties; or 5) contain a virus or other harmful or potentially harmful component.

 

You agree to indemnify, defend, and hold harmless Noven Therapeutics LLC, its affiliates, and subsidiaries, and their respective officers, directors, employees, agents, representatives, information providers and licensors, and their respective heirs and assigns from and against any and all losses, expenses, damages, and costs, including attorneys’ fees, resulting from any violation by you of the Terms of Use.

 

This site may provide links to other web sites maintained by third parties over which Noven Therapeutics LLC has no control. Noven Therapeutics LLC is not responsible for accuracy or any other aspect of the information contained on such sites and shall not be liable for any damages or injury arising from users’ access to such sites. Links to other sites are provided only as a convenience to users of our site. Noven Therapeutics LLC makes no representations or warranties of any kind as to the accuracy, completeness, or currency of any information provided on such sites.

 

Should any visitor to the Noven Therapeutics LLC site provide information such as questions, comments, suggestions, ideas, or the like through any feedback mechanisms located herein, except as set forth in the Noven Therapeutics Internet Privacy Statement, Noven Therapeutics LLC shall have no obligation of any kind with respect to such information and shall be free to reproduce, use, disclose, and distribute the information to others without limitation. Please refer to Noven Therapeutics LLC’s Privacy Policy with respect to users’ rights and information that is disclosed on this website.

 

Use of this web site, the Terms of Use and the Privacy Policy are governed by the laws of the United States and the State of Florida, without reference to choice of law doctrine. Nothing contained in these Terms of Use shall be construed as creating any agency, partnership or other form of joint enterprise between us. Our failure to require your performance of any provision hereof shall not affect the full right to require such performance at any time thereafter, nor shall our waiver of a breach of any provision hereof be taken or held to be a waiver of the provision itself.

 

If any provision of these Terms of Use is held to be unlawful, void or unenforceable, then such provision shall be severable without affecting the enforceability of all remaining provisions. Noven reserves the right to alter or delete materials from this web site at any time at its discretion.

The recommended storage conditions for COMBIPATCH have been updated.

The recommended storage conditions for COMBIPATCH have been updated.

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July 2022

IMPORTANT PRESCRIBING INFORMATION

Subject: New Packaging Reflecting Updated Storage Conditions for CombiPatch®
(estradiol/ norethindrone acetate transdermal system)
Dear Health Care Provider,
 
In December 2021, Noven Pharmaceuticals Inc., announced a change in the storage conditions for CombiPatch® (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg/day and 0.05/0.25 mg/day, approved by the U.S Food and Drug Administration (FDA).
 
The new storage condition only allows to “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.
 
Please note that the earliest patients will see changes to the outer packaging of CombiPatch reflecting these storage condition changes is September 2022. We advise you to please continue to proactively inform any patients receiving CombiPatch of its updated storage conditions.
 
Prescriber Action:
Continue to 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.
 

 

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