{"id":22594,"date":"2025-01-22T14:40:40","date_gmt":"2025-01-22T06:40:40","guid":{"rendered":"https:\/\/flcube.com\/?p=22594"},"modified":"2025-01-22T14:40:42","modified_gmt":"2025-01-22T06:40:42","slug":"fda-lifts-clinical-hold-on-sanofis-cialis-over-the-counter-trial","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=22594","title":{"rendered":"FDA Lifts Clinical Hold on Sanofi’s Cialis Over-the-Counter Trial"},"content":{"rendered":"\n

France-based Sanofi’s (NASDAQ: SNY<\/a>, EPA: SAN<\/a>) Consumer Healthcare unit Opella has announced that the US FDA has lifted a clinical hold on its planned Actual Use Trial (AUT) for Cialis (tadalafil). This move allows Sanofi to initiate the AUT and potentially switch the PDE5 inhibitor from a prescription to an over-the-counter (OTC) medicine.<\/p>\n\n\n\n

Purpose of Actual Use Trials<\/strong>
AUTs are designed to evaluate the use of a medicine under real-world conditions, identifying any issues not previously detected and confirming that consumers can self-diagnose and treat themselves appropriately without healthcare provider assistance. This step is crucial for ensuring the safety and efficacy of OTC medications.<\/p>\n\n\n\n

Cialis Background and Regulatory History<\/strong>
Cialis, originated by US-based Eli Lilly and Company (NYSE: LLY<\/a>), was first approved in the European Union (EU) in 2002 and later in the US for erectile dysfunction in 2003 and benign prostatic hyperplasia in 2011. In May 2014, Lilly and Sanofi reached a deal granting Sanofi exclusive OTC regulatory filing rights in the US, Europe, Canada, and Australia. Sanofi initially planned to complete all registration approvals for Cialis after its patent expiration in 2017, aiming to relist it as an OTC drug. However, the FDA suspended the AUT for Cialis in May 2022 due to potential issues in protocol design.<\/p>\n\n\n\n

Future Outlook<\/strong>
With the FDA’s decision to lift the clinical hold, Sanofi is now poised to proceed with the AUT, bringing Cialis one step closer to becoming an OTC option. This development could significantly expand access to the medication for consumers, aligning with Sanofi’s broader strategy to enhance its OTC portfolio.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

France-based Sanofi’s (NASDAQ: SNY, EPA: SAN) Consumer Healthcare unit Opella has announced that the US…<\/p>\n","protected":false},"author":1,"featured_media":22595,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[16,199,931,867,911,147],"class_list":["post-22594","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-eli-lilly","tag-epa-san","tag-nasdaq-sny","tag-nyse-lly","tag-sanofi"],"yoast_head":"\nFDA Lifts Clinical Hold on Sanofi's Cialis Over-the-Counter Trial - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"France-based Sanofi's (NASDAQ: SNY, EPA: SAN)Consumer Healthcare unit Opella has announced that the US FDA has lifted a clinical hold on its planned Actual Use Trial (AUT) for Cialis (tadalafil). 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