Regulatory Milestones
Regulatory milestone records preserve dated events that shape the obesity treatment market. These may include submissions, approvals, assessment outcomes, label changes, safety communications, shortage notices, post-marketing commitments, and other jurisdiction-specific regulatory developments.
This area should treat regulatory status as contextual and time-bound. Records need clear dates, jurisdictions, affected products or ingredients, related companies, and source context so readers can distinguish historical events from current status.
Future milestone pages should connect back to drug and product records, active ingredients, companies, clinical programs, mechanisms, and market access context where those relationships are reliable and useful.
This is a starting US-centered milestone map, not a complete regulatory history. Dates below identify regulatory events that help connect drugs, active ingredients, companies, mechanisms, and clinical programs.
April 23, 1999 - Xenical approval
Section titled “April 23, 1999 - Xenical approval”The FDA approved Xenical, the prescription orlistat product, creating an early regulatory record for a lipase-inhibitor obesity treatment in the US market. This milestone connects Xenical, orlistat, lipase inhibition, and orlistat-related company records.
Source: Drugs@FDA Xenical record
February 7, 2007 - Alli nonprescription approval
Section titled “February 7, 2007 - Alli nonprescription approval”The FDA approved Alli, a lower-dose nonprescription orlistat product, for over-the-counter use. This milestone is important because it connects an obesity-related active ingredient to both prescription and nonprescription distribution channels.
Source: Drugs@FDA Alli record
July 17, 2012 - Qsymia approval
Section titled “July 17, 2012 - Qsymia approval”The FDA approved Qsymia, a phentermine/topiramate extended-release product, for chronic weight management in adults. This milestone connects Qsymia to oral fixed-dose combination products and to VIVUS-related company records.
Source: Drugs@FDA Qsymia record
September 10, 2014 - Contrave approval
Section titled “September 10, 2014 - Contrave approval”The FDA approved Contrave, a naltrexone/bupropion extended-release product, for chronic weight management in adults. This milestone connects Contrave to oral fixed-dose combination products and to company records that should preserve dated ownership and commercialization context.
Source: Drugs@FDA Contrave record
December 23, 2014 - Saxenda approval
Section titled “December 23, 2014 - Saxenda approval”The FDA approved Saxenda, the liraglutide product for chronic weight management. This milestone connects liraglutide, Novo Nordisk, the SCALE clinical program, and the GLP-1 receptor agonist category.
Source: Drugs@FDA Saxenda record
February 13, 2020 - Belviq withdrawal request
Section titled “February 13, 2020 - Belviq withdrawal request”The FDA requested withdrawal of Belviq and Belviq XR from the US market after review of a required post-marketing safety trial. This record is useful for preserving regulatory safety context, but it should not be generalized to other obesity products or mechanisms.
Source: FDA Belviq withdrawal request
June 4, 2021 - Wegovy approval
Section titled “June 4, 2021 - Wegovy approval”The FDA approved Wegovy, the semaglutide product for chronic weight management. This milestone connects semaglutide, Novo Nordisk, the STEP clinical program, and the GLP-1 receptor agonist category in the US obesity-treatment market.
Source: FDA Wegovy approval notice
November 8, 2023 - Zepbound approval
Section titled “November 8, 2023 - Zepbound approval”The FDA approved Zepbound, the tirzepatide product for long-term weight reduction and maintenance in a defined adult population. This milestone connects tirzepatide, Eli Lilly, the SURMOUNT clinical program, and the GIP/GLP-1 receptor agonist category.
Source: FDA Zepbound approval notice
March 8, 2024 - Wegovy cardiovascular-risk indication
Section titled “March 8, 2024 - Wegovy cardiovascular-risk indication”The FDA approved an added Wegovy indication to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight. This milestone should be handled as a dated label event with indication-specific scope.
Source: FDA Wegovy cardiovascular-risk approval notice
December 20, 2024 - Zepbound obstructive sleep apnea indication
Section titled “December 20, 2024 - Zepbound obstructive sleep apnea indication”The FDA approved Zepbound for moderate to severe obstructive sleep apnea in adults with obesity. This milestone connects tirzepatide and Eli Lilly to an additional obesity-related indication and should be preserved with its date, population, and label scope.
Source: FDA Zepbound obstructive sleep apnea approval notice