Evicenter
P&T meetings

Saroglitazar

Primary biliary cholangitis

Manufacturer
Zydus Therapeutics
Regulatory submission
NDA submitted by May 2026
Last updated
81 sources

Product information and disease descriptionProduct description

Phase of product development

7 evidence topics · 8 sources

Orphan designation and FDA approval status
FieldQuoted record
Date designated“01/26/2021”
FDA orphan approval status“Not FDA Approved for Orphan Indication”
Fast Track designation

“has granted “Fast Track Designation” to Saroglitazar Mg” (opens the source at this quote in a new tab)

European orphan status

“Saroglitazar Mg has received Orphan Status from EMA for PBC” (opens the source at this quote in a new tab)

Regulatory submission: NDA submitted by May 2026

“So, it's filed but we are awaiting the acceptance?” (opens the source at this quote in a new tab)

“Yeah, we have to await the acceptance of the NDA, which is the more important milestone.” (opens the source at this quote in a new tab)

FDA review
FieldQuoted information
NDA review designation“Priority Review”
PDUFA target action date“November 27, 2026”
Launch: Anticipated in April 2027, the start of Zydus fiscal year 2028

“So, on Saro, I mean, we are building for next FY28 launch right now, so April launch.” (opens the source at this quote in a new tab)

Approvals outside the United States: MASH and MASLD publication

“approved by the Drug Controller General of India (DCGI), for the treatment of MASH and MASLD in India in 2020.” (opens the source at this quote in a new tab)

Exact FDA submission date; FDA Advisory Committee meeting date

No evidence found.