On March 19, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of generic versions of the drug Boniva (ibandronate). Boniva, manufactured by Genentech Inc., is a once-monthly tablet used in the treatment and prevention of osteoporosis in women. These recent FDA approvals are the first allowing the sale of generic versions of Boniva.
Generic drugs are approved by a process where a drug sponsor submits an Abbreviated New Drug Application (“ANDA”). In contrast to New Drug Applications (“NDAs”), an ANDA is considered “abbreviated” because the drug sponsor is typically not required to submit preclinical (animal) or clinical (human) data to support a submission. Rather, drug sponsors are able to gain approval of generic drugs by demonstrating that the generic is bioequivalent, i.e., “performs in the same manner” as the brand name or “innovator” drug. More information about the FDA’s approval of generic drugs may be found here.