Please See Important Safety Information, Including Boxed Warning Below

Privacy Policy

Validus Pharmaceuticals LLC. ("Validus") respects the privacy of visitors to its websites, and we recognize your need for appropriate protection and management of personally identifiable information you share with us (any information by which you can be identified, including but not limited to, name, address, e-mail address, and telephone number). That is why we have established this Privacy Policy, so that you are informed about how we treat any personally identifiable information that you provide to us in the course of using this website. Please note that this Privacy Policy is limited to website information only. This Privacy Policy will inform you of:

  1. How you will be informed of updates to this Privacy Policy
  2. What personally identifiable information of yours we may collect from you through our website
  3. How we may use your personally identifiable information
  4. Limits on how we would share and disclose your personally identifiable information
  5. Our policy regarding links to third party websites
  6. Security of our website
  7. How you can correct and update your personally identifiable information

Please note that the Validus websites are directed towards users who reside in the United States of America. It is not our intent to gather personally identifiable information from individuals residing outside the U.S.

Privacy Policy Updates - Due to the Internet's rapidly evolving nature, Validus may need to update this Privacy Policy from time to time. If so, Validus will post its updated Privacy Policy on our websites so that users are always aware of what personally identifiable information we may collect and how we may use this information. Validus encourages you to review this Privacy Policy regularly for any changes. Your continued use of this website will be subject to the then-current Privacy Policy.

Information Collection and Use - You can generally visit our website without revealing any personally identifiable information about yourself. However, to access certain options and services we may ask you to provide certain personally identifiable information and without providing such personally identifiable information, you may be unable to access certain options and services. We collect personally identifiable information about you only if you voluntarily provide it to us and you have the option not to provide any personally identifiable information to us. The following is personally identifiable information that you may voluntarily provide to us and how we use it:

  • Surveys. Information obtained from you on web surveys, such as contact information (name and address), demographic information (zip code, age level) and medical condition. We may use this personally identifiable information to provide you with information and services for which you have expressed an interest or that you may find useful based on your answers in a survey. Additionally, we may refer to your personally identifiable information to better understand your needs and how we can improve our website. Newsletters. Information obtained from you from your request to subscribe to a newsletter, such as contact information (name and e-mail address). We may use this personally identifiable information to deliver the newsletters that you have elected to receive.
  • Registration. Information obtained from you on registration forms used to process your requests for services and information, such as contact information (name, address, e-mail address), password, username or code, age, date of birth, gender, ethnicity and medical condition. This registration information may also be gathered if you register for certain services via fax or mail. We may use this information to send you a welcoming e-mail to verify your username and password, website updates, special offers, notices regarding relevant medical conditions and treatment, or other information responsive to the data that you provide to us. Additionally, we may refer to your personally identifiable information to better understand your needs and how we can improve our website.
  • Employment. Information obtained from you on registration forms to process your requests to create an account to access job postings and to post your resume, such as contact information (name, e-mail address, mailing address), password, username or code, employment history and any other personally identifiable information contained in your resume that you post to the website. We may use your personally identifiable information to send you a welcoming e-mail to verify your username and password, for employee recruitment purposes and to respond to your requests for information.
  • E-mail Content to a Friend. Information obtained from you regarding friend or family name and e-mail address, if you elect to use our referral service for sending some of our website content to friends and family. We may use this personally identifiable information to automatically send the friend or family member a one-time e-mail inviting them to visit the website. We may store this information for the sole purpose of sending this one-time e-mail.

Validus Pharmaceuticals LLC. is the owner of all information collected on this website.

Minors - You must be 18 years of age or older to submit registration or survey information. If you are under the age of 18 and wish to register to obtain further information or be included in a survey, then your parent or legal guardian must register to obtain the information or to participate in the survey.

Cookies and GIF files - Some of our websites may use cookie technology to identify users who have previously visited so the user is recognized upon return, thereby saving them time while on our website. A cookie is a piece of data stored on the user's hard drive containing information about the user. Usage of a cookie is in no way linked to any personally identifiable information while on our website. Once the user closes their browser, the cookie simply terminates. If a user rejects the cookie, they may still use our website. A cookie may be placed by us, or by vendors or service agencies who work with us or with our partners.

Log Files and Aggregate Information - We may track the total number of visitors to our website, the number of visitors to each page of our website, IP addresses, and the domain names of our users' Internet Service Providers, and we may analyze these data for trends and statistics in the aggregate, but such information will be in aggregate form only and it will not contain personally identifiable data. Such aggregate information is not linked to any personally identifiable information that can identify any individual person. We may use such aggregate information to analyze trends, administer the website and gather broad demographic information for aggregate use. We may share this aggregate information with our corporate partners and contracted vendors to assist us in operating the website and to enable them to better understand our business.

Sharing and Disclosure - We may provide your personally identifiable information that we collect and the data generated by cookies to a parent, subsidiary or affiliate entity within the Validus corporate family, partner entities, and the vendors and service agencies that we may engage to assist us. For example, we may provide your personally identifiable information to an organization in order to complete a service (e.g., send out newsletter e-mails you have requested), to assist us in reviewing or collating the data or to provide marketing or advertising on our behalf. Any organization to which we provide such personally identifiable information is also required to keep your personally identifiable information confidential in accordance with this Privacy Policy. We will also disclose your personally identifiable information if we reasonably believe we are required to do so by law, regulation or other government authority (such as reporting safety information to the Food and Drug Administration). We will not sell your personally identifiable information to any other company or organization except we may transfer your personally identifiable information to a successor entity upon a merger, consolidation or other corporate reorganization in which Validus Pharmaceuticals LLC. participates or to a purchaser of all or substantially all of our assets. Such successor entity shall be bound by the terms and conditions of this Privacy Policy.

Links to Third Party Sites - Some of our websites may contain links to other websites on the Internet that are not under the control of or maintained by Validus. Such links do not constitute an endorsement by Validus of those other websites, the content displayed therein, or the persons or entities associated therewith. You acknowledge that Validus is providing these links to you only as a convenience, and you agree that Validus is not responsible for the content of such websites. Your use of these other linked websites is subject to the respective terms of use and privacy policies located on the linked websites.

Security - Validus and its third party providers may employ procedural and technological security measures, consistent with industry practice. Such measures are reasonably designed to protect your personally identifiable information from loss, unauthorized access, disclosure, alteration or destruction. Validus may use encryption, password protection, secure socket layers, internal restrictions and other security measures to help prevent unauthorized access to your personally identifiable information.

Correction/Updating Personally Identifiable Information - Validus provides you with the ability to review and correct any of the personally identifiable information that you have provided to us. If you wish to correct any information provided to us, you may update your contact information directly by accessing your account or registration or you may contact Validus by webmaster@validuspharma.com. You may also "opt-out" of receiving e-mails and other communications from us by using the unsubscribe feature included in the e-mails we send.

Contact Information for Privacy Questions: Should you have any questions about this Privacy Policy or Validus' information collection or use and disclosure practice, you may contact us at the address most relevant to you. You may access this list of addresses online at http://validuspharma.com. Please note that excepts where required by law, Validus cannot ensure a response to questions or comments regarding topics unrelated to this Privacy Policy or Validus' privacy practices.

Privacy Policy Last Updated: August 9, 2011

WARNING

Important Safety Information about Equetro® (carbamazepine) Extended-Release Capsules

Warning Serious Dermatologic Reactions and HLA-B*1502 Allele

Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported during treatment with carbamazepine. These reactions are estimated to occur in 1 to 6 per 10,000 new users in countries with mainly caucasian populations, but the risk in some Asian countries is estimated to be about 10 times higher. Studies in patients of Chinese ancestry have found a strong association between the risk of developing SJS/TEN and the presence of HLA-B*1502, an inherited allelic variant of the HLA-B gene. HLA-B*1502 is found almost exclusively in patients with ancestry across broad areas of Asia. Patients with ancestry in genetically at-risk populations should be screened for the presence of HLA-B*1502 prior to initiating treatment with Equetro® (carbamazepine) Extended-Release Capsules. Patients testing positive for the allele should not be treated with Equetro® (carbamazepine) Extended-Release Capsules unless the benefit clearly outweighs the risk (see warnings and precautions, laboratory tests).

Aplastic Anemia and Agranulocytosis

Aplastic Anemia and Agranulocytosis have been reported in association with the use of carbamazepine. Data from a population based case-control study demonstrate that the risk of developing these reactions is 5–8 times greater than in the general population. However, the overall risk of these reactions in the untreated general population is low, approximately six patients per one million population per year for Agranulocytosis and two patients per one million population per year for Aplastic Anemia.

Although reports of transient or persistent decreased platelet or white blood cell counts are not uncommon in association with the use of carbamazepine, data are not available to estimate accurately their incidence or outcome. However, the vast majority of the cases of leukopenia have not progressed to the more serious conditions of Aplastic Anemia or Agranulocytosis.

Because of the very low incidence of Agranulocytosis and Aplastic Anemia, the vast majority of minor hematologic changes observed in monitoring of patients on carbamazepine are unlikely to signal the occurrence of either abnormality. Nonetheless, complete pretreatment hematological testing should be obtained as a baseline. If a patient in the course of treatment exhibits low or decreased white blood cell or platelet counts, the patient should be monitored closely. Discontinuation of the drug should be considered if any evidence of significant bone marrow depression develops.

Anti-epileptic drugs (AEDs), including Equetro®, may increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence of worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Please see FULL PRESCRIBING INFORMATION including contraindications, warnings and precautions, and boxed warning for additional safety information on Equetro® (carbamazepine) Extended-Release Capsules.

Please see Medication Guide for additional information.