State Regulations, Declarations, and Disclosures
The following is information that may affect marketing, sales and other activities at ALK-Abelló, Inc. (hereinafter “ALK”). In accordance with state laws, ALK is disclosing this information in the form required.
California
Annual Declaration of Compliance for the State of California
Comprehensive Compliance Program for the State of California
Colorado Wholesale Acquisition Cost Information for Prescribers
In accordance with the Colorado Wholesale Acquisition Cost Disclosure Law (Colorado Revised Statutes Section 12-42.5-308), ALK is disclosing to authorized prescribers of prescription drugs in Colorado certain required wholesale acquisition cost (WAC) pricing information for ALK marketed products.
Please choose a product from the list and select “Disclosure Letter” below.
GRASTEK® (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use |
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ODACTRA® House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract Tablet for Sublingual Use |
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RAGWITEK® (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use |
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HISTATROL® (histamine phosphate) Positive Control |
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HISTATROL® (histamine phosphate) Positive Control Intradermal |
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PRE-PEN® (benzylpenicilloyl polylysine injection USP) Skin Test Antigen |
Disclosure Letter |
Connecticut Wholesale Acquisition Cost Information for Prescribing Practitioners and Pharmacists
In accordance with Connecticut Public Act No. 23-171, ALK is disclosing to prescribing practitioners and pharmacists in Connecticut certain required wholesale acquisition cost (WAC) pricing information for ALK marketed legend drugs.
Please choose a product from the list and select “Disclosure Letter” below.
GRASTEK® (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use |
|
ODACTRA® House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract Tablet for Sublingual Use |
|
RAGWITEK® (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use |
|
HISTATROL® (histamine phosphate) Positive Control |
|
HISTATROL® (histamine phosphate) Positive Control Intradermal |
|
PRE-PEN® (benzylpenicilloyl polylysine injection USP) Skin Test Antigen |
Disclosure Letter |
Vermont Pharmaceutical Marketer Price Disclosure
In accordance with the Vermont Pharmaceutical Marketer Price Disclosure Law (18 V.S.A. Section 4633), ALK is disclosing certain required pricing information to individuals authorized to prescribe prescription drugs that ALK markets, as well as disclosing pricing information for other prescription drugs in the same therapeutic class.
Please choose a product from the list and select “Disclosure Letter” below.
GRASTEK® (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use |
|
ODACTRA® House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract Tablet for Sublingual Use |
|
RAGWITEK® (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use |
|
HISTATROL® (histamine phosphate) Positive Control |
|
HISTATROL® (histamine phosphate) Positive Control Intradermal |
|
PRE-PEN® (benzylpenicilloyl polylysine injection USP) Skin Test Antigen |
Disclosure Letter |
The pricing information disclosed represents the WAC price, which represents the manufacturer’s published catalogue or list price for a drug product to wholesalers as reported to third-party drug pricing publishers. WAC does not represent actual transaction prices and does not include discounts, rebates or reductions in price. The price paid by patients to acquire the products listed is often different than the WAC prices listed, and most patients do not pay WAC. How much a patient will pay will depend on the patient’s insurance coverage. To learn the exact cost of a prescription, patients should contact their health insurance company or preferred pharmacy. Pricing information listed does not imply safety or efficacy of the product, and no comparisons should be made.
The listing of Other Products in the disclosure forms is not intended to imply that such Other Products are interchangeable with the marketed product or have the same efficacy or safety. Please refer to each product's FDA-approved prescribing information for such determinations.
The listing of generic products in the disclosure forms does not imply that such products are interchangeable with the ALK marketed product or have the same efficacy or safety. Please refer to each product's U.S. Food and Drug Administration (FDA)-approved prescribing information for further information.
The Other Products identified on disclosure forms are the other products listed in the same therapeutic class as the marketed product in the American Hospital Formulary Service ("AHFS") Pharmacologic-Therapeutic Classification system. Certain states require manufacturers to use the AHFS classification system to determine which products are in the same therapeutic class and should be listed on the disclosure form. The AHFS Pharmacologic-Therapeutic Classification is available on the internet at http://www.ahfsdruginformation.com/.
When the price per pill is disclosed, it is derived from Average Wholesale Prices (AWP) as established and made available to the public by a third-party publisher or as calculated from data made available to the public by a third-party publisher. We are required to use these prices for the disclosure forms.
The prescribing information approved by the FDA must continue to guide appropriate use of ALK medicines. The intent of this website is only to provide wholesale acquisition price information to authorized prescribers of prescription drugs in specific states in accordance with their laws. For more detailed information or healthcare advice, members of the public should consult their healthcare professionals.