PP10-76: Generic Ophthalmic Products: Regulatory Considerations for Product Quality

Poster Presenter

Asif Rasheed

Review Scientist, OLDP, OPQ, CDER
FDA
United States

Objectives

The shortcomings in submissions for abbreviated new drug applications (ANDAs) particularly for topical ophthalmic drug products will be the focus of this presentation.

Method

Presentation will highlight issues and common deficiencies found in submissions for different ophthalmic dosage forms such as solutions, suspensions and emulsions and offer strategy to minimize those.

Results

The approval of Abbreviated New Drug Applications (ANDAs) or generic products including ophthalmic products has significantly increased over the years particularly since the Generic Drug User Fee Amendments (GDUFA) was initiated in 2012. Besides the rise of generic drug approval every year and FDA and Office of Generic Drug (OGD) continually reporting record number of approvals, several generic drug product manufacturers continue to present shortcomings in the ANDA specifically for ophthalmic drug products. The shortcomings in ANDA submissions particularly for topical ophthalmic drug products will be the focus of this presentation. Presentation will highlight issues and common deficiencies found in submissions pharmaceutical development, product specifications, container closure systems and stability considerations) for different ophthalmic dosage forms such as solutions, suspensions and emulsions and offer strategy to minimize those.

Conclusion

The shortcomings in ANDA submissions particularly for topical ophthalmic drug products will be the focus of this presentation. Presentation will highlight issues and common deficiencies found in submissions pharmaceutical development, product specifications, container closure systems and stability considerations) for different ophthalmic dosage forms such as solutions, suspensions and emulsions and offer strategy to minimize those.