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Privacy Policy

Welcome to the Vernalis.com website (together with the websites of all related entities, the “Site”). The Site is owned by one of the Vernalis family of companies (“Vernalis”). This Privacy Policy is designed to tell you about our practices regarding the collection, use and disclosure of information you may provide on the Site. Please read the entire Privacy Policy carefully before submitting information on the Site. This Site is intended for the use by residents of the United States.

By using the Site, you signify your agreement to this Privacy Policy and Vernalis’s Terms of Use. Whenever you submit information via this Site, you consent to the collection, use and disclosure of that information in accordance with this Privacy Policy and the Terms of Use.

What Information is collected?

We may ask you to provide us with personal information in certain areas of our Site on a voluntary basis.

In particular, you may be asked to provide information in the following situations:

✔  Information Requests: If you submit an e-mail requesting or providing information, we will use this information to respond to your request. In order to respond to your request we may make personal information that you submit in these sections available to Vernalis, our affiliates, and, in some circumstances to certain of our service providers. These entities may be located primarily within the U.S. and countries within the European Union.

✔  Careers Services: If you want to apply for a position with Vernalis through the Site, you will be asked to submit general information (such as your name and email address), together with a copy of your resume. Your resume may be transferred to any of the Vernalis affiliates throughout the world. Vernalis will use this information for purposes of processing your hiring application and for corresponding with you. Vernalis is an equal opportunity employer.

✔  Passive Information: Currently, we do not use cookies or other technology to gather personal information, although we may do so in the future to enable personalization of information provided on this Site. This privacy policy will be updated before we begin to use any such technology.

Some of the information that you submit to us may be “personally identifiable information” (that is, information that can be uniquely identified with you, such as your full name, address, e-mail address, phone number, and so on). By voluntarily providing and submitting this information to us, you knowingly consent to our use of this information in accordance with this Privacy Policy. You are under no obligation to provide this personally identifiable information to us. If you do not want us to collect your personally identifiable information, please do not provide it to us.

Vernalis may also collect non-personal information, such as IP addresses, numbers of site visits and tracking patterns of page viewing in order to monitor the performance of the Site and to make improvements to it.

Sharing and Disclosure of Information

Personally identifiable information may be used, by way of example, for such purposes as to deliver services, such as information, newsletters or other information that you request; to develop or continue a business relationship with you; to respond to your requests for information about products or services or to respond to any other question posed by you; for employment purposes; and for legal compliance, such as adverse event reporting.

We may share or disclose your personally identifiable information in the following instances:

✔  To contractors if necessary to support our business (e.g., technical support providers);

✔  To protect the personal safety of users of Vernalis products and services, the Site or the public;

✔  In connection with the sale, assignment or other transfer of the business of this Site; or

✔  If required to do so by applicable laws, court orders, government regulations or authorities

Access and Correction: You have a right to know about the personal information that Vernalis holds about you. You also have a right to correct, amend or delete the information that Vernalis holds about you if it is incorrect. If you wish to exercise these rights please contact us by post or electronic mail at the address shown in the “Contact” section below.

External Links

This Site may provide links to various websites that we do not control. When you click on one of these links, you will be transferred out of our Site and connected to the website of the organization or company that you selected. Even if an affiliation exists between our Site and a third-party website, we exercise no control over linked sites. Each of these linked sites maintains its own independent privacy and/or data collection policies and procedures. If you visit a website that is linked to our Site, you should consult that site’s privacy policy before providing any personal information.

Children

This Site is not directed to children and Vernalis does not knowingly solicit information from any child under the age of 18. We will not knowingly collect personally identifiable information via the Site from visitors in this age group.

International Users

Any information you provide to Vernalis through use of the Site may be stored and processed, transferred between and accessed from the United States and other countries which may not guarantee the same level of protection of personal information as the one in which you reside. However, Vernalis will handle your personal information in accordance with this Privacy Policy regardless of where your personal information is stored/accessed. In addition, please note that Vernalis abides by the Safe Harbor framework agreed to by the U.S. Department of Commerce and the EU/Switzerland with respect to certain categories of personal information collected by entities located in the European Economic Area and Switzerland and transferred to Vernalis in the United States.

Safe Harbor Policy

Vernalis has subscribed to and will adhere to the U.S.-EU and U.S.-Swiss Safe Harbor Policy by adopting and implementing the Safe Harbor Privacy Principles issued by the U.S. Department of Commerce on July 21, 2000.

Any Personal Information sent to us may be used by Vernalis and its agents for the purposes indicated in notices and policies that Vernalis has previously made available to you. Such purposes include, for example, carrying out and supporting Vernalis’s clinical research, pharmacovigilance and adverse event reporting activities; responding to product complaints and medical inquiries; and complying with certain legal and regulatory obligations. If we intend to use your information for a purpose that is incompatible with these purposes or if we intend to disclose it to a type of third party not previously identified, we will notify you and offer you the opportunity to opt out of such uses and/or disclosures where it involves non-sensitive information or opt-in where sensitive information is involved.

We sometimes use other companies and individuals to perform functions or services on our behalf. They may have access to personal information to perform their functions, but are restricted from using the personal information for purposes other than for providing services to Vernalis. Any agent or service provider is required to subscribe to the Safe Harbor Principles.

Data Integrity

We take reasonable steps to ensure that personal information we process is reliable for its intended use, is accurate, complete, and current to the extent necessary for the purposes for which we use the information.

Security

We use reasonable precautions to protect personal information from the loss, misuse, and unauthorized access, disclosure, alteration and destruction. This Site incorporates appropriate safeguards to protect the security, integrity, completeness, accuracy and privacy of the personal information we have collected. Our security and privacy policies are periodically reviewed and enhanced as required and only authorized individuals have access to the information you provide us.

If you have any questions or concerns, please write to us at: privacy@vernalis.com or the address listed in the contact information below. We will investigate and attempt to resolve complaints and disputes regarding use and disclosure of personal information in accordance with the Safe Harbor Principles.

Terms and Modifications to Privacy Policy

Vernalis may modify this Privacy Policy at any time, at its discretion and modifications are effective upon being posted on this Site. You are responsible for reviewing this Privacy Policy periodically to ensure that you are aware of any changes to it.

Contact Details

If you have any questions about this Privacy Policy, the privacy practices of this Site or if you want to exercise any of the rights that you are given under this privacy statement you can contact: privacy@vernalis.com.

Last Updated: October 19, 2015

See also our Terms of Use Agreement

© 2016 Vernalis Therapeutics, Inc.

Privacy Policy  |  Terms of Use

MOXATAG is a licensed trademark of Vernalis Therapeutics, Inc.

© 2016 Vernalis Therapeutics, Inc. All rights reserved.

MOX-0019-01 09/2016

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INDICATION:

MOXATAG (amoxicillin extended-release) Tablets is a penicillin-class antibacterial indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes (S. pyogenes) in adults and pediatric patients 12 years and older.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of MOXATAG and other antibacterial drugs, MOXATAG should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Important Safety Information:

Contraindications

Patients with known serious hypersensitivity to amoxicillin or to other drugs in the same class or patients who have demonstrated anaphylactic reactions to beta-lactams

Warnings and Precautions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens, so careful inquiry about a history of hypersensitivity reactions to penicillins, cephalosporins or other allergens should be made. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated.

Clostridium difficile associated diarrhea (ranging from mild diarrhea to fatal colitis) has been reported with nearly all antibacterial agents, including amoxicillin. Evaluate if diarrhea occurs.

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, amoxicillin should be discontinued and appropriate therapy instituted.

Mononucleosis rash: Ampicillin-class antibiotics should not be administered to patients with mononucleosis because a high percentage develops a rash.

Risk of development of drug-resistant bacteria is increased by prescribing amoxicillin in the absence of proven or strongly suspected bacterial infection or treating prophylactically and is unlikely to provide benefit to the patient.

False-positive urinary glucose tests may occur with amoxicillin. Glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix®) are recommended.

Adverse Reactions

The most common drug-related adverse reactions (incidence ≥1.0 %) are vulvovaginal mycotic infection, diarrhea, nausea, vomiting and headache.

To report SUSPECTED ADVERSE REACTIONS, contact Vernalis Therapeutics, Inc. at 1-855-705-9546 and www.vernalistherapeutics.com or FDA at 1-800 -FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.

Reduced efficacy of combined oral estrogen/progesterone contraceptives may result from use of amoxicillin or other antibiotics.

Use in Specific Populations

Pediatrics: The safety and effectiveness of MOXATAG in pediatric patients younger than 12 years has not been established.

Renal Impairment: MOXATAG has not been studied in patients with renal impairment; however a reduction of amoxicillin dose is generally recommended for patients with severe renal impairment. Therefore, MOXATAG is not recommended for use in patients with severe renal impairment (CrCl < 30 mL/min) or patients on hemodialysis.

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