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# 40 DTC Untitled Letters Posted by FDA
- URL: https://www.fdaweb.com/40-dtc-untitled-letters-posted-by-fda/
- Published: 2025-09-16T12:00:00.000Z
- Updated: 2026-09-14T15:21:45.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5159875

FDA has released 40 cease and desist (untitled) letters to drug companies that the agency said were issued earlier this month when it unveiled a major push ([see earlier story](https://www.fdaweb.com/fda-orders-crackdown-on-misleading-prescription-drug-ads/)) to crack down on misleading direct-to-consumer drug advertising.

For example, a [letter to AstraZeneca](https://www.fda.gov/media/188697/download?attachment&ref=fdaweb.com) addresses a specific DTC TV commercial that was false and misleading and contained incomplete risk representation. The ad depicts people doing everyday, active things: exploring, sightseeing, splashing, playing with a dog, etc., while being treated with Calquence. The visuals give the impression that patients can maintain a normal, active lifestyle during treatment with minimal disruption. However, FDA says, “adverse reactions are most likely to happen when patients first begin using the drug, when they discontinue it, or when the dosage changes,” and that frequent monitoring with a healthcare provider is required. These aspects were downplayed, it says.

In a [letter to Boehringer Ingelheim Pharmaceuticals](https://www.fda.gov/media/188746/download?attachment&ref=fdaweb.com) about a DTC broadcast ad for Jardiance (empagliflozin tablets), FDA determined that it was false or misleading, thereby misbranding the drug. The ad features fast-paced visuals, including choreographed dancing at a “movie night” event, flashing cameras, and movie-related props. The agency says that such attention-grabbing elements compete for a viewer’s attention, undermining the presentation of important information about Jardiance. The agency says the ad also inadequately presented risk information because the major statement, which communicates the drug’s most serious risks, is presented with frequent scene changes and competing visuals.

And, a [letter to AbbVie ](https://www.fda.gov/media/188750/download?attachment&ref=fdaweb.com)cites a DTC television ad for Linzess (linaclotide) that FDA determined was false or misleading. Specifically, it says the major statement is presented from frames 10 through 16, but during this segment, the ad depicts a series of quick scene changes and visuals that interfere with a viewer’s ability to comprehend the information.

Links to the letters are below (some companies have multiple letters):

- 9/9/2025 Alnylam Pharmaceuticals, Inc. [Untitled Letter](https://www.fda.gov/media/188686/download?attachment&ref=fdaweb.com) Amvuttra (vutrisiran)
- 9/9/2025 BridgeBio Pharma, Inc. [Untitled Letter](https://www.fda.gov/media/188687/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188688/download?attachment&ref=fdaweb.com) Attruby (acoramidis)
- 9/9/2025 Teva Neuroscience [Untitled Letter](https://www.fda.gov/media/188719/download?attachment&ref=fdaweb.com) Austedo XR (deutetrabenazine)
- 9/9/2025 Teva Neuroscience, Inc. [Untitled Letter](https://www.fda.gov/media/188720/download?attachment&ref=fdaweb.com) Austedo XR (deutetrabenazine)
- 9/9/2025 Axsome Therapeutics, Inc. [Untitled Letter](https://www.fda.gov/media/188689/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188690/download?attachment&ref=fdaweb.com) AUVELITY(dextromethorphan hydrobromide and bupropion hydrochloride)
- 9/9/2025 UCB [Untitled Letter](https://www.fda.gov/media/188691/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188692/download?attachment&ref=fdaweb.com) Bimzelx (bimekizumab-bkzx)
- 9/9/2025 UCB [Untitled Letter](https://www.fda.gov/media/188693/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188694/download?attachment&ref=fdaweb.com) Bimzelx (bimekizumab-bkzx)
- 9/9/2025 UCB [Untitled Letter](https://www.fda.gov/media/188695/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188696/download?attachment&ref=fdaweb.com) Bimzelx (bimekizumab-bkzx)
- 9/9/2025 AstraZeneca Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188697/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188698/download?attachment&ref=fdaweb.com) Calquence (acalabrutinib)
- 9/9/2025 Bristol Myers Squibb [Untitled Letter](https://www.fda.gov/media/188699/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188700/download?attachment&ref=fdaweb.com) Camzyos (mavacamten)
- 9/9/2025 Nalpropion Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188701/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188702/download?attachment&ref=fdaweb.com) Contrave (naltrexone hydrochloride and bupropion hydrochloride)
- 9/9/2025 Azurity Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188703/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188704/download?attachment&ref=fdaweb.com) Danziten (nilotinib)
- 9/9/2025 AstraZeneca Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188717/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188718/download?attachment&ref=fdaweb.com) Fasenra (benralizumab)
- 9/9/2025 AstraZeneca Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188732/download?attachment&ref=fdaweb.com); Fasenra (benralizumab)
- 9/9/2025 AstraZeneca Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188733/download?attachment&ref=fdaweb.com) Fasenra (benralizumab)
- 9/9/2025 Takeda Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188752/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188753/download?attachment&ref=fdaweb.com) Fruzaqla (fruquintinib)
- 9/9/2025 Takeda Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188744/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188741/download?attachment&ref=fdaweb.com) Fruzaqla (fruquintinib)
- 9/9/2025 Neurocrine Biosciences [Untitled Letter](https://www.fda.gov/media/188721/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188722/download?attachment&ref=fdaweb.com) Ingrezza (valbenazine)
- 9/9/2025 Novartis Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188723/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188724/download?attachment&ref=fdaweb.com) Kesimpta (ofatumumab)
- 9/9/2025 Boehringer Ingelheim Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188746/download?attachment&ref=fdaweb.com) Jardiance (empagliflozin tablets)
- 9/9/2025 Boehringer Ingelheim Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188747/download?attachment&ref=fdaweb.com) Jardiance (empagliflozin tablets)
- 9/9/2025 Boehringer Ingelheim Pharmaceuticals, Inc. [Untitled Letter](https://www.fda.gov/media/188748/download?attachment&ref=fdaweb.com) Jardiance (empagliflozin tablets)
- 9/9/2025 Bausch Health Companies [Untitled Letter](https://www.fda.gov/media/188749/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188742/download?attachment&ref=fdaweb.com) Jublia (efinaconazole)
- 9/9/2025 Novartis Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188751/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188745/download?attachment&ref=fdaweb.com) Kisqali (ribociclib)
- 9/9/2025 AbbVie, Inc. [Untitled Letter](https://www.fda.gov/media/188750/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188743/download?attachment&ref=fdaweb.com) Linzess (linaclotide)
- 9/9/2025 ARS Pharmaceutical Operations [Untitled Letter](https://www.fda.gov/media/188705/download?attachment&ref=fdaweb.com) Neffy (epinephrine nasal spray)
- 9/9/2025 Galderma Laboratories [Untitled Letter](https://www.fda.gov/media/188706/download?attachment&ref=fdaweb.com) Nemluvio (nemolizumab-ilto)
- 9/9/2025 Bristol-Myers Squibb [Untitled Letter](https://www.fda.gov/media/188707/download?attachment&ref=fdaweb.com) Opdivo Qvantig (nivolumab and hyaluronidase-nvhy)
- 9/9/2025 Bristol-Myers Squibb [Untitled Letter](https://www.fda.gov/media/188708/download?attachment&ref=fdaweb.com) Opdivo (nivolumab) and Yervoy (ipilimumab)
- 9/9/2025 Supernus Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188725/download?attachment&ref=fdaweb.com) [Promotional Material](https://www.fda.gov/media/188726/download?attachment&ref=fdaweb.com) Qelbree (viloxazine extended-release capsules)
- 9/9/2025 Supernus Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188727/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188728/download?attachment&ref=fdaweb.com) Qelbree (viloxazine extended-release capsules)
- 9/9/2025 AbbVie, Inc. [Untitled Letter](https://www.fda.gov/media/188729/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188730/download?attachment&ref=fdaweb.com) Quilpta (atogepant)
- 9/9/2025 Novartis Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188710/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188711/download?attachment&ref=fdaweb.com) Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
- 9/9/2025 AstraZeneca Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188712/download?attachment&ref=fdaweb.com) Truqap (capivasertib)
- 9/9/2025 Sanofi [Untitled Letter](https://www.fda.gov/media/188713/download?attachment&ref=fdaweb.com) Tzield (teplizumab-mzwv)
- 9/9/2025 Pfizer [Untitled Letter](https://www.fda.gov/media/188715/download?attachment&ref=fdaweb.com); [Promotional Material](https://www.fda.gov/media/188716/download?attachment&ref=fdaweb.com) Velsipity (etrasimod)
- 9/9/2025 Phathom Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188755/download?attachment&ref=fdaweb.com) Voquezna (vonoprazan)
- 9/9/2025 Phathom Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188754/download?attachment&ref=fdaweb.com) Voquezna (vonoprazan)
- 9/9/2025 Phathom Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188756/download?attachment&ref=fdaweb.com) Voquezna (vonoprazan)
- 9/9/2025 Alexion Pharmaceuticals [Untitled Letter](https://www.fda.gov/media/188731/download?attachment&ref=fdaweb.com) Ultomiris (ravulizumab-cwvz)