Manufacturer Notices to Covered Entities

2020

Vertex Pharmaceuticals Inc. Notice of Limited Distribution Plan (PDF - 132 KB)

Notice for Resticted Distribution Network for Sublocade (PDF - 158 KB)

Exelixis Notice of Distribution Model for Cabometyx (PDF - 154 KB)

Notice Regarding Repatha Replacement (PDF - 80 KB)

Updated Notice of Distribution Model for Cometriq (PDF - 132 KB)

Notice of Change in Distribution Model for TYMLOS® (PDF - 545 KB)

Notice Regarding Recalculated 340B ceiling prices for Apotex Corp (PDF - 15 KB)

Distribution Plan for certain generic products for Bausch Health (PDF - 111 KB)

Limited Distribution Notice for NUPLAZID® (pimavanserin) Tablets and Capsules (PDF - 67 KB)

Notice Regarding Recalculated 340B Ceiling Prices for Certain Products of Astellas Pharma US, Inc. (PDF - 167 KB)

Notice of Change in Distribution Model for Kitabis™ Pak (NDC 24492-850-56) (PDF - 347 KB)

340B Notice Regarding Limited Distribution Plan for AYVAKIT™ (avapritinib) (PDF - 169 KB)

Notice Regarding Adjustment of 340B Prices for Select Products of Purdue Pharma L.P. and Avrio Health L.P. (PDF - 256 KB)

Notice to 340B Covered Entities Regarding Replacement NDCS For Enbrel® (PDF - 95 KB)

2019

Notice to 340B Covered Entities That Purchased Xspire Products (PDF - 135 KB)

Amended Limited Distribution System for PROGRAF® (Tacrolimus) Ampules and Granules and ASTAGRAF XL® (Tacrolimus Extended-release Capsules) (PDF - 322 KB)

340B Limited Distribution Notice for Corlanor® (ivabradine) Oral Solution 5 mg (NDC 55513-0813-28) (PDF - 82 KB)

Updated Notice to 340B Covered Entities Regarding Panzyga Immune Globulin Intravenous (Human) ifas 10% Liquid Preparation (PDF - 73 KB )

Notice to 340B Covered Entities Regarding Cutaquig Immune Globulin Subcutaneous (Human)-hipp 16.5% Solution (PDF - 113 KB)

Notice of Change in Distribution Model for Adrenalin and Vasostrict (PDF - 339 KB)

Notice to 340B Covered Entities Regarding Calcium Acetate (Generic) Capsules (PDF - 86 KB)

340B Notice Exclusive Oncology Distribution Network Update for Iclusig (ponatinib) (PDF - 160 KB)

Updated 340B Limited Distribution Notice for Xermelo (PDF - 147 KB)

340B Notice Regarding Updated Limited Distribution Plan for Nulojix (belatacept) (PDF - 132 KB)

Daiichi Sankyo Notice to 340B Covered Entities Regarding Turalio™ (PDF - 38 KB)

Notice to 340B Covered Entities Regarding GAMMAKED [Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified] (PDF - 79 KB)

Notice to 340B Covered Entities Related to Axumin™ (NDC # 69932-0001-01) (PDF - 107 KB)

Notice to Covered Entities Regarding Balversa Limited Distribution Plan (PDF - 68 KB)

340B Limited Distribution Notice for OXERVATE (NDC 71981-0020-01) (PDF - 152 KB)

Notice Regarding Recalculated 340B Price for Amphastar Pharmaceuticals, Inc. (PDF - 84 KB)

Notice Regarding Recalculated 340B Ceiling Prices for The Medicines Company Products (PDF - 88 KB)

Notice Regarding Adjustment of 340B Prices for Purdue Pharma L.P. (PDF - 272 KB)

Millennium Pharmaceuticals Notice Regarding Adjustment of 340B Prices for Velcade (PDF - 44 KB)

Vifor Mircera Notice of End of Limited Distribution Plan (PDF - 273 KB)

BioMarin Pharmaceuticals - Palynziq Notice to Covered Entities of Limited Distribution Plan (PDF - 46 KB)

Catalyst FIRDAPSE® (amifampridine) tablets Notice Regarding Limited Distribution Plan (PDF - 205 KB)

Notice Regarding Adjustment of 340B Prices for Select Products of Kedrion Biopharma, Inc. (PDF - 362 KB)

Notice Regarding Recalculated 340B Prices for Sebela Products (PDF - 230 KB)

Notice Regarding Adjustment of 340B Prices for Select Products of Purdue Pharma L.P. (PDF - 106 KB)

NOTIFICATION OF SUPPLY ALLOCATION: TICE® BCG (BCG LIVE for intravesical use) (PDF - 54 KB)

Array Biopharma Notice of Defined Distribution Network for BRAFTOVl® (encorafenib) and MEKTOVI* (binimetinib) (PDF - 94 KB)

Insmed Limited Distribution Plan for ARIKAYCE (PDF - 52 KB)

2008-2015

2015: Notice Regarding Limited Distribution Network for Reylimid, Pomalyst and Thalomid (PDF - 95 KB)

2014: Bayer Limited Distribution System for Betaseron (PDF - 66 KB)

2013: Bayer Skyla Letter (PDF - 117 KB) 05/31/2013

2011: Yaz® Limited Distribution System (PDF - 21 KB) 03/30/2011

2009: Limitations on Sales of Venofer® (PDF - 18 KB) 10/29/2009

2008: Yasmin® Limited Distribution System (PDF - 21 KB) 09/30/2008

Accessibility

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Date Last Reviewed:  March 2020