State Regulations & Product Disclosures

The following is information that may affect marketing, sales and other activities at Averitas Pharma. In accordance with state laws, Averitas Pharma is disclosing this information in the form required.

CALIFORNIA: STATEMENT REGARDING COMPLIANCE WITH CALIFORNIA HEALTH AND SAFETY CODE § 119402
Last Updated: July 1, 2024 

This information is provided pursuant to the requirements of California Health and Safety Code, Section 119402, which requires pharmaceutical companies doing business in California to make available their Compliance Program and annual written declaration of compliance with the Compliance Program. 

California Health and Safety Code, Sections 119400-119402, (“California Compliance Law”) requires pharmaceutical companies to adopt a compliance program in accordance with the April 2003 publication “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Compliance Guidance”) developed by the United States Department of Health and Human Services Office of Inspector General (“OIG”) and policies for compliance with the Pharmaceutical Research and Manufacturers of America (“PhRMA”) “Code on Interactions with Health Care Professionals” (“PhRMA Code”) within six months of any update or revision of the PhRMA Code. Revisions to the July 1, 2002 PhRMA Code were effective January 2009. 

Averitas Pharma, Inc., and GRT US Holding, Inc., (all three companies collectively the “Company”) have established a Company Compliance Program in accordance with the OIG Compliance Guidance and have policies in place to foster compliance with the PhRMA Code for their pharmaceutical businesses. This Company Compliance Program is part of the US Compliance Program and Global Compliance Framework. For purposes of compliance with the requirements of the California Compliance Law and as part of the Company Compliance Program, the Company has established a specific annual aggregate dollar limit of $2,000 on gifts, promotional materials, or items or activities that the Company may give or otherwise provide to an individual medical or healthcare professional licensed in California on an annual basis from January 1st to December 31st each year. Such items or activities primarily include: modest meals associated with a substantive discussion of a Company product or a disease state; medical textbooks and other items that principally entail a patient benefit or are related to the healthcare professional’s practice; and other items or activities permitted under the PhRMA Code, and/or the OIG Compliance Guidance. These items and activities are primarily directed to the dissemination or communication of medical and scientific information as a resource for healthcare professionals to assist in making clinical or other medical judgments. This limit may be revised from time to time, in which case the revised limit will be published in this section of the Company website. This limit represents a spending cap, not a goal or average; in many cases, the amount spent per physician may be substantially less than the cap amount. The Company has established an internal monitoring system designed to help ensure compliance with the annual spending limits in California and is working to establish additional monitoring processes. 

The annual limits do not include the following:

• Drug samples given to physicians and healthcare professionals

• Financial support for continuing medical education program

• Financial support for educational scholarships

• Payments for bona fide professional services made pursuant to a contract, and any meals or expenses associated with the provision of such services

Annual Declaration (July 1, 2024) 

As stated in its Company Compliance Program description, the Company is committed to conducting its business ethically and in compliance with all applicable laws. To the best of its knowledge and based on a good faith understanding of the statutory requirements, the Company has established a Company Compliance Program that meets the requirements set forth in California Health and Safety Code, Sections 119400-119402. The Company has tailored its Company Compliance Program to meet the specific needs of the Company and continuously assesses the effectiveness of the Company Compliance Program. The Company has established an internal monitoring system designed to help ensure compliance with its respective annual spending limits in California and is working to establish additional corporate tracking and monitoring processes. Thus, subject to the limitations described above, the Company declares that, based upon current tracking and monitoring systems, the Company is, in all material respects, in compliance with the Compliance Program. 

As recognized by the OIG Compliance Guidance, even an effective compliance program cannot eliminate the possibility that one or more individual employees engage in conduct that would be considered improper. Accordingly, this declaration is not intended and should not be construed to imply that the Company has not identified any individual instances in which an employee has or may have violated one or more provisions of its Company Compliance Program. In such situations, the Company takes reasonable and appropriate remedial or corrective action in a manner consistent with its Company Compliance Program. 

For a written copy of the Compliance Program description or this declaration, call 1-833-211-3671.

‍COLORADO: Colorado HB 19-1131 Product Disclosure Details
Last Updated: September 3, 2024
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The product pricing and competitor information provided below is being disclosed as prescribed by Colorado HB 19-1131. The notice below provides the Wholesale Acquisition Cost (“WAC”) and the names of generic prescription drugs available in the same therapeutic class as Averitas Pharmaceuticals products based on the products’ labeled indications.

The prices listed below are WAC prices as published by MediSpan. WAC prices are representative of the price paid by wholesalers but the actual price paid by consumers may differ significantly from the WAC prices listed below. Further, the WAC prices listed here do not necessarily reflect price per dosage, price per course of treatment or the cost effectiveness, of all the products listed.

This list does not imply that the products on this chart are interchangeable or have the same efficacy or safety. Please refer to each product’s FDA-approved label and indication for further information.

‍CONNECTICUT: Public Act Number 23-171 HCP Price Disclosure
Last Updated: September 3, 2024
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The product pricing and competitor information provided below is being disclosed as required by Connecticut Public Act Number 23-171. The notice below provides the Wholesale Acquisition Cost (“WAC”) and the names of generic prescription drugs available in the same therapeutic class as Averitas Pharmaceuticals products based on the products’ labeled indications.

The prices listed below are WAC prices as published by MediSpan. WAC prices are representative of the price paid by wholesalers, but the actual price paid by consumers may differ significantly from the WAC prices listed below. Further, the WAC prices listed here do not necessarily reflect price per dosage, price per course of treatment or the cost effectiveness, of all the products listed.

This list does not imply that the products on this chart are interchangeable or have the same efficacy or safety. Please refer to each product’s FDA-approved label and indication for further information.