Harrow Acquires Global TYRVAYA Rights from Viatris, Including Pending MAAs Across Multiple Markets

For regulatory affairs leads managing multi-jurisdictional product transfers, Harrow's acquisition of TYRVAYA® (varenicline solution nasal spray 0.03 mg) from Viatris introduces a layered compliance handover spanning three active approvals and an open queue of pending marketing authorization applications.

Harrow announced on 6 August 2026 that it has entered a definitive agreement to acquire global rights to TYRVAYA from Viatris Inc. The product holds current regulatory approvals in the U.S., China, and Taiwan, with marketing authorization applications pending in additional markets. As a cholinergic agonist indicated for the signs and symptoms of dry eye disease, TYRVAYA carries the distinction of being the only FDA-approved nasal spray in its therapeutic category.

The regulatory transfer workload here is substantial. Each active approval jurisdiction carries its own CMC documentation package, and any manufacturing site changes triggered by the acquisition will require prior approval supplements or equivalent filings under local frameworks. In the U.S., that means alignment with 21 CFR Part 314 post-approval change requirements; in China and Taiwan, parallel submissions to the NMPA and TFDA respectively. GMP compliance continuity across the handover period will be a near-term operational priority for both quality teams.

The pending MAAs add a further dimension. Harrow will inherit applications at varying stages of review, each potentially requiring updated applicant information, revised labeling, or supplementary CMC data to reflect the ownership change. Coordinating those updates without disrupting review timelines demands close engagement with each health authority and a clear internal accountability structure across regulatory, quality, and supply-chain functions.

For plant heads and QA directors, the sterility assurance profile of a nasal spray product warrants early attention during due diligence close-out. Nasal drug products manufactured under 21 CFR Part 211 require documented process validation for each production site, and any site transfer as part of the acquisition will reset validation obligations under the receiving facility's quality management system, consistent with ICH Q10 lifecycle principles.

Harrow, headquartered in Nashville and positioned as a North American ophthalmic disease management provider, has not disclosed financial terms of the transaction or a projected close date. The scope of pending MAA jurisdictions has also not been specified in the announcement.

The measurable checkpoint for regulatory teams will be the first post-close submission to an active-approval authority confirming applicant transfer without disruption to the existing approval status.

Source: GlobeNewswire via Harrow corporate announcement, 6 August 2026.