This bill amends the Federal Food, Drug, and Cosmetic Act to accelerate generic drug availability by modifying the 180-day exclusivity period for first applicants. It introduces a new provision allowing the Secretary to approve an abbreviated new drug application (ANDA) from a subsequent applicant under specific conditions, even if a first applicant is eligible for exclusivity. This aims to prevent delays in market entry when a first applicant fails to commence commercial marketing. For such early approval, the subsequent applicant must certify their intent to begin commercial marketing within 75 days of approval, and at least 33 months must have passed since the first applicant's submission. The bill also establishes a special forfeiture rule : if a subsequent applicant fails to market the drug within the 75-day period, their effective approval becomes tentative. They can regain effective approval only by certifying that an unforeseen event prevented marketing and that the issue has been fully resolved. These changes apply to ANDAs filed after the bill's enactment date, for which no prior Paragraph IV certification existed.