Zydus Lifesciences Bags FDA Green Light for Major US Multiple Sclerosis Drug Launch!

Reviewed By

Satyam Jha | Whalesbook News Team

Detailed Coverage:

Zydus Lifesciences has achieved a significant milestone with the final approval from the United States Food and Drug Administration (USFDA) for its Diroximel Fumarate delayed-release capsules. This medication, available in 231 mg strength, is prescribed for adults with relapsing forms of multiple sclerosis (MS) and is a generic version of Vumerity. The drug will be manufactured at Zydus's Special Economic Zone (SEZ) facility located in Ahmedabad, India. The US market presents a substantial opportunity, with IQVIA MAT data from September 2025 indicating that Diroximel Fumarate capsules had annual sales of USD 999.4 million. This latest approval brings Zydus's total USFDA approvals to 426, stemming from 487 Abbreviated New Drug Application (ANDA) filings since FY2003-04. In related news, the USFDA recently conducted a pre-approval inspection at Zydus's oncology injectable manufacturing site in Ahmedabad, which concluded with two observations; however, the company confirmed no data integrity issues and will work on addressing the observations. This regulatory success follows Zydus's robust Q2 FY26 performance, which saw a 39% year-on-year increase in net profit to ₹1,259 crore and a 17% rise in revenue to ₹6,123 crore, largely driven by its US and India formulation businesses. Impact: This USFDA approval is a powerful positive catalyst for Zydus Lifesciences. It unlocks access to a high-value market for a drug with proven sales, directly contributing to revenue growth and strengthening the company's market position. The strong financial performance reported alongside this news further enhances investor confidence and the company's overall outlook. Impact: 8/10. Definitions: USFDA: United States Food and Drug Administration, the primary federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, etc. Multiple Sclerosis (MS): A chronic, often disabling disease that affects the central nervous system, including the brain and spinal cord. Generic Version: A pharmaceutical drug that contains the same active ingredients as a brand-name drug and is bioequivalent, typically produced after patent protection expires. ANDA: Abbreviated New Drug Application, a submission to the USFDA for approval to market a generic drug. IQVIA MAT data: Moving Annual Total sales data over the preceding 12 months, compiled by IQVIA, a global healthcare data analytics firm.