Federal Register Notice; correction: A request for revision of the regulatory review period for Boniva was filed for the product on 7/25. FDA reviewed its records and found that the effective date of the investigational new drug application was incorrect because of a clerical error. Therefore, FDA has determined that the applicable adjusted regulatory review period for Roche/GlaxoSmithKline’s Boniva is 3,122 days for extending a patent which claims that human drug product. To view this notice, click here.