Fougera Privacy Policy

Privacy Statement

Issued April 2014

Who We Are
Thank you for your trust in Fougera and for taking the time to read our Privacy Policy. We are an affiliate of the Novartis Group, world leaders in healthcare with core businesses in pharmaceuticals, consumer health, generics, vaccines and diagnostics. This Privacy Policy tells you how we protect the privacy of personal information that you may provide to us.

"Safe Harbor" Certification for Privacy

As part of our commitment to privacy, Fougera has certified to the Safe Harbor privacy program. The Safe Harbor program is co-sponsored by the European Commission, the Swiss Federal Data Protection and Information Commission and the US Department of Commerce. This means that Fougera has voluntarily implemented a set of privacy standards that are approved by the United States, European and Swiss governments for companies in the United States. Only a small percentage of US companies have certified to the Safe Harbor privacy standards. More information about our Safe Harbor privacy standards is provided in the link below.

Please visit the Safe Harbor Privacy Statement. To learn more about the Safe Harbor program, and to view Fougera’s certification, please visit http://www.export.gov/safeharbor/.

Purpose of Privacy Policy

The purpose of this Privacy Policy is to explain what Fougera does with personally identifiable information that you provide to us, such as your name, mailing address or email address. We want you to know how your personally identifiable information will be protected, who we may share it with, and for what purposes.

Collection of Your Information

Many of our services do not require any form of registration or identification. However, some of our services may require registration. This allows us to send you information that you request or to contact you about Fougera products and services on either a one-time basis, or longer. Registration is optional but if you choose to withhold any personal data requested by us, it may not be possible for you to gain access to certain parts of the site or for us to provide the materials, information or services that you would like to receive.

Data Integrity

Fougera takes reasonable steps to ensure that personal data collected is reliable for its intended use, accurate, complete, and current. Fougera limits the collection and processing of personal information to what is necessary to fulfill the intended purpose.

Consent to Provide Your Information to Fougera

We request your permission to collect your personally identifiable information when you seek to register for a Fougera program or service. In doing so, we also explain the purpose for the collection of your personal information and how we plan to use it. We also offer you the option to discontinue your consent ("opting out" or "unsubscribing") if you later decide that you no longer want to participate in a program or service. If we wish to use this information for purposes other than those for which the data was initially collected, we will offer a means to opt out of the secondary use.

Collection of Anonymous Computer Information

When you visit our websites, we do not collect any personally identifiable information about you without your permission. However, we do collect anonymous information about you if your computer is set to allow that type of collection. (You can turn off the ability to collect some of this information on most computers.) This type of anonymous information allows us to evaluate customer interest in our websites and perform other market research activities, such as surveying browsing habits on our sites. It also allows us to monitor traffic to our websites. (For those who are interested in the details, some of the typical computer techniques we may use are "cookies," "internet tags" which are also called "action tags," "single-pixel GIFs," “clear GIFs,” "invisible GIFs,” and "1-by-1 GIFs”). If you would like more information about web tags and cookies associated with on-line advertising or how to opt-out of third-party collection of information, please visit the Network Advertising Initiative website, an independent website not sponsored by or affiliated with Fougera.

Sharing Your Information With Third-Parties

Fougera will not share your personal information with unaffiliated third-parties, such as marketers, for their own separate use unless we have obtained your opt-in consent to do so. When you provide personally identifiable information to Fougera, it will be accessible to some of Fougera’s and Novartis' business partners, such as companies we retain to fulfill requests for information, or provide assistance to us on specific programs or projects. In those cases, the other companies may also have access to your personally identifiable information. Fougera requires third-parties to whom it discloses personal data to protect personal information using substantially similar standards to those required by Fougera. We also require that they not use your personal information for any separate use that is not specifically authorized by Fougera.

There may also be instances where Fougera may be required to share your information with third-parties who have not been retained by us (directly or indirectly), for example, if we are required to do so because of an applicable law, court order or governmental regulation, or if such disclosure is otherwise necessary in support of any criminal or other legal investigation or proceeding here or abroad. Many entities receiving personally identifiable information under these conditions have privacy requirements that apply to their handling of your information.

Personal Information collected from you may also be transferred to a third party in the event that the business of this site or a part of it and the customer data connected with it is sold, assigned or transferred, in which case we would require the buyer, assignee or transferee to treat your information in accordance with this Privacy Statement.

Sharing Your Information Within the Novartis Group of Companies

The information that you provide to Fougera may sometimes be shared with Novartis subsidiaries and affiliates within the Novartis global group. This may mean that your personally identifiable information may be transferred outside of the US to Novartis affiliates in other countries. Other departments within the Novartis group, and other Novartis companies that may receive your information will abide by substantially similar privacy requirements relating to your personally identifiable information.

Security of Your Information

We use appropriate technical, administrative and physical safeguards to protect data that pertains to you from loss, misuse or alteration. Of course, no organization can guarantee the absolute security of personal information. You should keep in mind that Internet transmissions, particularly email transmissions, are never 100% secure or error-free. Accordingly, we also caution you to guard your own computer and password against unauthorized access by others.

Links to Other Sites

This Privacy Statement applies only to this website and not to third party websites. We may provide links to other websites which we believe may be of interest to our visitors. We aim to ensure that such websites are of a high standard. However, due to the nature of the World Wide Web, we cannot guarantee the privacy standards of websites to which we link or be responsible for the contents of sites other than this one. This Privacy Statement is not intended to be applicable to any linked, non-Fougera site.

Transfer of Your Information

When Fougera transfers personal information to countries other than the country where the information was provided, we do so in compliance with applicable privacy laws. We endeavor to protect personal information entrusted to us no matter what country it is stored in or transferred to and seek to have appropriate procedures in place to help ensure the security of your personal information. As noted above, we also adhere to the US Department of Commerce's Safe Harbor standards concerning the transfer of personal data from the European Union and Switzerland to the United States of America.

Protection of Children

Fougera will not knowingly collect, use or disclose personally identifiable information from a minor under the age of 13, without obtaining prior consent from a person with parental responsibility (parent or guardian). Fougera abides by the Children's Online Privacy Protection Act (COPPA) in the United States, and respects similar laws of other countries that protect the privacy of children. Should a child whom we know to be under 13 provide personally identifiable information to us, we will use that information only to respond directly to that child to inform him or her that we must have parental consent before receiving information about him or her.

Updating and Accessing Your Information

We encourage you to update the information that you provide to us, such as providing us with a new mailing or email address. This will help us continue to provide information to you that best meets your needs.

In addition, Fougera complies with laws and regulations applicable to the right to amend your data in our files. These rights are limited in some ways. In addition, in order to protect your data from unauthorized access or alteration by third parties, all requests to update or access your information will be subject to verification of the identity of the requesting individual.

Updated Fougera Privacy Statement

This Privacy Statement becomes effective on April 1, 2014. Fougera may update this Privacy Statement from time to time. We encourage you to review our Privacy Policy periodically.

How to Contact Us

If you have any questions about our Privacy Policy, please write to us at Fougera Pharmaceuticals Inc., Attention Data Privacy Officer, 60 Baylis Road, Melville, NY 11747, or via e-mail at data.privacy@sandoz.com.

Fougera Safe Harbor Privacy Statement


Safe Harbor Standards

This Safe Harbor Privacy Statement (the "Statement") sets forth the privacy principles followed by Fougera which is Safe Harbor certified in connection with the transfer and protection of "personal information" received from the European Union (EU) or Switzerland.

About The Safe Harbor

The "Safe Harbor" program was jointly established by the United States Department of Commerce and the European Commission, as a method for transferring personal information from the European Union (EU), to companies in the United States. A similar arrangement was later reached between the US Department of Commerce and the Information Commissioner of Switzerland, so that the Safe Harbor program now includes the U.S.-EU Safe Harbor Framework and the U.S.-Swiss Safe Harbor Framework. The program is a voluntary self-certification process for companies operating in the United States. Companies that certify that they are upholding privacy standards for personal information received from the EU and Switzerland that have been accepted by the EU Commission, the Swiss Federal Data Protection and Information Commission and the US Department of Commerce. These standards exceed current US privacy standards. Fougera has certified to the Safe Harbor program and makes that same representation.

"Personal Information" means information that can directly or indirectly lead to the identification of a living person, such as an individual's name, address, e-mail, telephone number, license number, medical identification number, photograph, or other identifying characteristic. The identification can occur by reference to one or more factors specific to the individual's physical, physiological, mental, economic, cultural or social identity. Personal information does not include information that has been anonymized, encoded or otherwise stripped of its identifiers, or information that is publicly available, unless combined with other non-public personal information.

To learn more about the Safe Harbor program, and to view Fougera's certification, please visit http://www.export.gov/safeharbor/.

Scope

This Statement governs personal information transferred from countries in the EU or Switzerland (which has adopted substantially similar privacy laws to those of the EU), to the United States on behalf of Fougera. It applies to personal information in electronic and off-line formats.

Safe Harbor Privacy Principles

The following privacy principles apply to the transfer, collection, use or disclosure of personal information from the EU or Switzerland by Fougera.

Notice: Fougera informs individuals in the EU and Switzerland about the purposes for which it collects and uses their personal information, how to contact Fougera, the types of third parties with which Fougera shares their personal information, and the choice and means Fougera offers for limiting the use and disclosure of their personal information. Consistent with the Safe Harbor requirements, Fougera may not be in a position to furnish notice in certain limited situations. Specifically, notice is not required where the processing of EU or Swiss personal information is necessary to respond to a government inquiry; is required by applicable laws, court orders or government regulations; or is necessary to protect Fougera's legal interests and providing notice would interfere with those interests.

Choice: Fougera will not process personal information about EU or Swiss individuals for purposes other than those for which the information was originally obtained or subsequently authorized by the individual unless the individual affirmatively and explicitly consents ("opt-in") to the processing, or unless an exception applies. Fougera also provides EU and Swiss individuals with the opportunity to withdraw consent at any time ("opt-out"), in which case their personal information will not be further processed. There are certain limitations on the right to opt-out, such as those that apply in the clinical research situation. In that situation, Fougera can continue to rely upon personal information already provided by clinical research participants who choose to discontinue participation in a clinical trial, to the extent needed to protect the integrity of the study, but cannot collect any additional personal information about that individual once the written request to withdraw participation is received.

Data Integrity: Fougera seeks to ensure that any personal information held about EU and Swiss individuals is accurate, complete, current and otherwise reliable in relation to the purposes for which the information was obtained. Fougera collects personal information that is adequate, relevant and not excessive for the purposes for which it is to be processed. EU and Swiss individuals have a responsibility to assist Fougera in maintaining accurate, complete and current personal information about them.

Transfers To Third Parties: Fougera will only transfer personal information about EU and Swiss individuals to third-parties where the third-party (a) has provided satisfactory assurances to Fougera that it will protect the information consistently with this Statement; or (b) is located in the EU, Switzerland or a country considered "adequate" for privacy by the EU or Swiss Commission, and therefore is required to comply with the EU or Swiss data protection laws or substantially equivalent privacy laws depending upon where the personal information originated ; or (c) the third-party has also certified to the Safe Harbor, and is accordingly independently responsible for complying with the Safe Harbor requirements.
Where Fougera has knowledge that a third-party to whom it has provided EU or Swiss personal information is processing that information in a manner contrary to this Statement or the Safe Harbor requirements, Fougera will take reasonable steps to prevent or stop the processing.

Access and Correction: Upon written request to Fougera, Fougera will provide EU and Swiss individuals with reasonable access to their personal information. Fougera will also take reasonable steps to allow EU and Swiss individuals to review their information for the purposes of correcting their information. There are certain limitations to the Access and Correction rights, as set forth in the US Department of Commerce's Safe Harbor website (http://www.export.gov/safeharbor/).

Security: Fougera takes reasonable precautions to protect EU and Swiss personal information in its possession from loss, misuse, unauthorized access, disclosure, alteration and destruction.

Enforcement: Fougera has established internal mechanisms to verify its ongoing adherence to this Statement. Fougera also encourages individuals covered by this Statement to raise any concerns about our processing of their personal information by contacting the Fougera Data Privacy Officer at the address below. Fougera will seek to resolve any concerns. Fougera has also agreed to participate in the dispute resolution programs provided by the European Data Protection Authorities.

Limitation On Scope Of Principles: Adherence to these Privacy Principles may be limited to the extent required to meet a legal, governmental, national security or public interest obligation.

Contact Information: If you have questions or comments about this Statement, write to: Fougera Pharmaceuticals Inc., Attention Data Privacy Officer, 60 Baylis Road, Melville, NY 11747, or via e-mail at data.privacy@sandoz.com.

KERYDIN® Indication and Important Safety Information

Pandel® Cream Indication and Important Safety Information

OXISTAT® Cream and Lotion Indication and Important Safety Information

VEREGEN® Indication and Important Safety Information

ApexiCon® E Cream Indication and Important Safety Information

 

KERYDIN® Indication

KERYDIN® is a topical prescription medicine used to treat fungal infections of the toenails.

Important Safety Information

KERYDIN® is for use on toenails only. Do not use KERYDIN® in your mouth, eyes, or vagina.

Tell your doctor about all of your medical conditions, including if you are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed. It is not known if KERYDIN® can harm your unborn baby or if KERYDIN® passes into your breast milk. It is not known if KERYDIN® is safe and effective in children.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Use KERYDIN® exactly as your healthcare provider tells you to use it. Avoid getting KERYDIN® on skin that is not surrounding the treated toenail. KERYDIN® is flammable. Avoid heat and flame while applying KERYDIN® to your toenail.

KERYDIN® may cause irritation at the treated site. The most common side effects include skin peeling, ingrown toenail, redness, itching, and swelling. Tell your doctor if you have any side effect that bothers you or does not go away.

Please see link to Full Prescribing Information below.

KERYDIN® (tavaborole) Topical Solution, 5% Full Prescribing Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

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PANDEL® Cream Indication

PANDEL® (hydrocortisone probutate) Cream, 0.1% is a topical prescription medication for the relief of the inflammatory (redness) and pruritic (itching) manifestations of corticosteroid-responsive skin conditions in patients 18 years of age or older.

Important Safety Information

This medication is for topical use only. Avoid contact with the eyes. The treated skin area should not be bandaged or otherwise covered or wrapped, unless directed by the physician. Therapy should be stopped when your condition gets better. If no improvement is seen within two weeks, contact the physician.

PANDEL can pass through your skin and cause adrenal gland problems. This is more likely to happen if you use PANDEL for too long, use it with other medicines that contain corticosteroids, apply it on a large area of your skin or apply it on broken skin, cover the treated area, have liver failure, or use it in pediatric patients. Your healthcare provider may do blood tests to check your adrenal gland function during and after treatment with PANDEL. Various hormonal abnormalities, increased blood sugar, and revealing underlying diabetes mellitus can also result from topical corticosteroids passing through your skin. Pediatric patients may be more susceptible to systemic toxicity.

Allergic contact dermatitis (rash) with corticosteroids is usually identified by a failure to heal rather than worsening of the condition, as seen with most topical products not containing corticosteroids. If irritation develops, discontinue PANDEL and institute appropriate therapy.

If you are pregnant or nursing a baby, consult with your physician prior to using this product.

The most frequent adverse reactions include burning, stinging, rash, red, bumpy rash, redness, itching, moderate tingling or prickling feeling, and allergic rash. Local adverse reactions that have been reported with topical corticosteroids include itching, irritation, dryness, folliculitis (swelling of the hair follicles), hypertrichosis (excessive hair growth), acneiform eruptions (acne or rashes resembling acne), hypopigmentation (loss of skin color), perioral dermatitis (rash around the mouth), allergic contact dermatitis (rash), secondary infections, skin atrophy (thinning), striae (lines on the skin), and miliaria (rash due to blocking of the sweat glands, ‘prickly heat’).

Please see the link to the Full Prescribing Information below.

Pandel® (hydrocortisone probutate) Cream, 0.1% Full Prescribing Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

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OXISTAT® Cream and Lotion Indication

OXISTAT® Cream and OXISTAT® Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur.

OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.

Important Safety Information

Do not use OXISTAT® Cream and Lotion if you have hypersensitivity to any ingredient of this product.

Use the product only externally. OXISTAT® is not to be used in the eyes or vagina. Avoid contact with the eyes, nose, mouth, and other mucous membranes. Do not cover the treated area unless directed otherwise by your physician.

Use the medication for the full treatment time recommended by your physician, even though symptoms may have improved.

Inform the physician if the area of application shows signs of increased irritation, itching, burning, blistering, swelling, or oozing. In clinical studies with OXISTAT®, the most commonly reported side effects were itching and burning.

If you are pregnant or nursing a baby, consult with your physician prior to using this product. For more information, consult your physician.

Please see the link to the Full Prescribing Information below.

OXISTAT® (oxiconazole nitrate) Cream, 1% & Lotion, 1% Full Prescribing Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

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VEREGEN® Indication

VEREGEN® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

Important Safety Information

Do not use VEREGEN® Ointment, 15% if you are allergic to any ingredient in this product. Do not use VEREGEN® Ointment, 15% for warts in the vagina, cervix, or inside the anus. Avoid contact with your eyes, nostrils and mouth while ointment is on your finger(s).

Avoid use of VEREGEN® on open wounds. Do not expose skin that has been treated with VEREGEN® to the sunlight, sunlamps or tanning beds. Tell your doctor if you are using any other type of skin product on the area to be treated. Avoid sexual contact (genital, anal or oral) when VEREGEN® Ointment, 15% is on your genital or perianal skin. If you do choose to have sexual contact, you must wash off the ointment carefully before having protected sexual contact as the ointment may weaken condoms and vaginal diaphragms.

Be sure to tell the doctor if you have a weak immune system, if you are pregnant or nursing a baby, or if you have used VEREGEN® before. Avoid using this product in patients younger than 18 years of age or for longer than 16 weeks. If your warts do not go away or come back after treatment contact your doctor.

The most common side effects with VEREGEN® Ointment, 15% are local skin and application site reactions including: redness, itching, burning, pain, sores, swelling, hard spots, rash with blisters.

For more information, consult your healthcare professional.

You are encouraged to report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Please visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

If you have a product complaint about VEREGEN®, please call PharmaDerm customer service at 1-800-525-8747.

The information on this website should not take the place of talking with your healthcare professional. If you need medical information, please talk to your healthcare professional.

Please see link to full Patient Information. VEREGEN® (sinecatechins) Ointment, 15% Patient Information

Please see link to full Prescribing Information. VEREGEN® (sinecatechins) Ointment, 15% Full Prescribing Information

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ApexiCon® E Cream Indication

ApexiCon® E Cream is a topical prescription medication for the relief of the inflammatory (redness) and pruritic (itching) manifestations of corticosteroid-responsive skin conditions (such as atopic dermatitis or psoriasis).

Important Safety Information

Do not use ApexiCon® E Cream if you have a history of hypersensitivity to any of the ingredients of the preparation. If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. This medication is for external use only. Avoid contact with the eyes. The treated skin area should not be bandaged or otherwise covered or wrapped unless directed by the physician. Do not use tight-fitting diapers or plastic pants on an infant or child being treated in the diaper area, as this may increase the likelihood of the side effects.

Systemic absorption of topical corticosteroids through the skin has produced various hormonal abnormalities, increased blood sugar, and sugar in the urine in some patients. The following local side effects have been reported most commonly with topical corticosteroids: burning, itching, irritation, dryness.

The safety and effectiveness of this product in pediatric patients have not been established. Pediatric patients are more likely to develop toxicity affecting various organs. Side effects of topical steroids in children may include problems with growth, weight gain, headaches, problems with vision, bulging soft spots on a baby's head, and stretch marks.

If you are pregnant or nursing a baby, consult with physician prior to using this product.

For more information, consult your healthcare professional. Please see link to Full Prescribing Information below.

ApexiCon® E Cream (diflorasone diacetate cream USP 0.05% [emollient]) Full Prescribing Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

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