Viatris Inc

33 products tracked · names used in filings: Viatris Inc, Viatris Limited

Upcoming milestones

Sun 27 Dec 2026🇺🇸 PDUFA datecompany-announcedin 43 days

MR-107A-02: PDUFA target action date (moderate-to-severe acute pain)

Viatris Inc (VTRS); meloxicam; NDA; status: set; "The FDA has assigned a PDUFA goal date of December 27, 2026."; filed 2026-08-06 · source

Recent milestones

Sat 17 Oct 2026🇺🇸 PDUFA datecompany-announced

MR-141: PDUFA target action date (presbyopia)

Viatris Inc (VTRS); phentolamine ophthalmic solution 0.75%; sNDA; status: set; "The FDA has assigned a PDUFA goal date of October 17, 2026."; filed 2026-02-26 · source

Fri 18 Sep 2026🇪🇺 EU approval (EC decision)

Ruxolitinib Viatris (ruxolitinib hemifumarate) approved in the EU

Marketing authorisation to Viatris Limited; Generic · source

Thu 30 Jul 2026🇺🇸 PDUFA datecompany-announced

low-dose estrogen weekly patch: PDUFA target action date (contraception)

Viatris Inc (VTRS); norelgestromin and ethinyl estradiol; NDA; status: set; "The NDA was accepted under the FDA's 505(b)(2) regulatory pathway, and the FDA has assigned a PDUFA goal date of July 30, 2026."; filed 2026-02-26 · source

Thu 23 Jul 2026🇪🇺 CHMP positive opinion

Ruxolitinib Viatris (ruxolitinib hemifumarate): CHMP positive opinion

Viatris Limited; Generic · source

Fri 19 Jun 2026🇪🇺 EU approval (EC decision)

Palbociclib Viatris (palbociclib) approved in the EU

Marketing authorisation to Viatris Limited; Generic · source

Thu 23 Apr 2026🇪🇺 CHMP positive opinion

Palbociclib Viatris (palbociclib): CHMP positive opinion

Viatris Limited; Generic · source

Thu 08 Jan 2026🇪🇺 EU approval (EC decision)

Teduglutide Viatris (teduglutide) approved in the EU

Marketing authorisation to Viatris Limited; Generic · source

Thu 13 Nov 2025🇪🇺 CHMP positive opinion

Teduglutide Viatris (teduglutide): CHMP positive opinion

Viatris Limited; Generic · source

Products

ProductStatusApproved
🇪🇺Raltegravir Viatris
raltegravir potassium		Application withdrawn
🇪🇺Apremilast Viatris
apremilast		Application withdrawn
🇪🇺Ruxolitinib Viatris
ruxolitinib hemifumarate		Authorised2026-09-18
🇪🇺Palbociclib Viatris
palbociclib		Authorised2026-06-19
🇪🇺Teduglutide Viatris
teduglutide		Authorised2026-01-08
🇪🇺Nintedanib Viatris
nintedanib		Authorised2025-08-22
🇪🇺Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris
emtricitabine;rilpivirine;tenofovir alafenamide		Authorised2025-08-19
🇪🇺Emtricitabine / Tenofovir alafenamide Viatris
emtricitabine;tenofovir alafenamide		Authorised2025-07-18
🇪🇺Eltrombopag Viatris
eltrombopag		Authorised2024-12-12
🇪🇺Enzalutamide Viatris
enzalutamide		Authorised2024-08-22
🇪🇺Pomalidomide Viatris
pomalidomide		Authorised2024-02-16
🇪🇺Dapagliflozin Viatris
dapagliflozin		Authorised2023-03-24
🇪🇺Pirfenidone Viatris
pirfenidone		Authorised2023-01-10
🇪🇺Teriflunomide Viatris (previously Teriflunomide Mylan)
teriflunomide		Authorised2022-11-09
🇪🇺Rivaroxaban Viatris (previously Rivaroxaban Mylan)
rivaroxaban		Authorised2021-11-12
🇪🇺Ambrisentan Viatris (previously Ambrisentan Mylan)
ambrisentan		Authorised2019-06-20
🇪🇺Prasugrel Viatris (previously Prasugrel Mylan)
prasugrel		Authorised2018-05-15
🇪🇺Anagrelide Viatris (previously Anagrelide Mylan)
anagrelide		Authorised2018-02-15
🇪🇺Ritonavir Viatris (previously Ritonavir Mylan)
ritonavir		Authorised2017-11-09
🇪🇺Entecavir Viatris (previously Entecavir Mylan)
entecavir		Authorised2017-09-18
🇪🇺Febuxostat Viatris (previously Febuxostat Mylan)
febuxostat		Authorised2017-06-15
🇪🇺Talmanco (previously Tadalafil Generics)
tadalafil		Authorised2017-01-09
🇪🇺Darunavir Viatris (previously Darunavir Mylan)
darunavir		Authorised2017-01-03
🇪🇺Tenofovir disoproxil Viatris (previously Tenofovir disoproxil Mylan)
tenofovir disoproxil		Authorised2016-12-08
🇪🇺Mysildecard
sildenafil		Authorised2016-09-15
🇪🇺Atazanavir Viatris (previously Atazanavir Mylan)
atazanavir		Authorised2016-08-22
🇪🇺Rasagiline Viatris (previously Rasagiline Mylan)
rasagiline		Authorised2016-04-04
🇪🇺Zonisamide Viatris (previously Zonisamide Mylan)
zonisamide		Authorised2016-03-31
🇪🇺Lopinavir/Ritonavir Viatris (previously Ritonavir Mylan)
lopinavir;ritonavir		Authorised2016-01-14
🇪🇺Pregabalin Viatris (previously Pregabalin Mylan)
pregabalin		Authorised2015-06-24
🇪🇺Duloxetine Viatris (previously Duloxetine Mylan)
duloxetine		Authorised2015-06-19
🇪🇺Clopidogrel Viatris (previously Clopidogrel Taw Pharma)
clopidogrel		Authorised2009-10-16
🇪🇺Olanzapine Viatris (previously Olanzapine Mylan)
olanzapine		Authorised2008-10-06

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.