Mumbai, Dec 10: Pharma major Zydus said hat United States Food and Drug Administration (USFDA) has granted “Fast Track Designation” to Saroglitazar Mg for the treatment of patients with Primary Biliary Cholangitis (PBC).
Fast Track is a process of the USFDA which expedites the review of drugs to treat serious conditions and fill an unmet medical need.
A drug that receives Fast Track designation is eligible for Accelerated Approval and Priority Review, if the relevant criteria are met. The purpose is to get important new drugs to the patients faster.
The global market for primary biliary cholangitis treatment is expected to grow at a CAGR of 36.3 pc from 2018 – 2026 and is expected to reach USD 10.8 bn by 2026 as per Coherent market insights. (UNI)
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