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Generic Drugs Outlined As ‘Significant Public Health Priority’ For FDA

Generic Cyclosporine Was A Significant Win For FDA Last Year

Executive Summary

The FDA Office of Generic Drugs has published its annual report, highlighting its contributions to the approval of Viatris’ generic cyclosporine rival to Restasis, alongside updates to bioequivalence standards and support for competition.

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FDA Guides On Generic Product-Specific Meetings, Under GDUFA III Commitment

With GDUFA III now almost at the five-month stage, the FDA has released draft guidance on product-specific guidance (PSG) meetings between FDA and a prospective applicant, as part of commitments set forth under the Generic Drug User Fee Act.

Closing The Books On GDUFA II

Approval and submission data indicate steady trends aside from one outlier year.

Surprise! Viatris Proves Its Worth With First Generic Restasis Approval

In one of the most keenly-watched markets, Viatris has emerged as the winner of approval for the first US generic version of AbbVie’s Restasis 0.05% ophthalmic emulsion, years after its IP was taken down. Numerous firms and analysts had acknowledged the complexity of the reference brand.

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