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The FDA approved 42 new drugs and biologics of note in 2012. About half are pharmacologically similar to others already marketed (see Table 70-2). Among the remainder are 16 first-in-class agents indicated for the management of a variety of conditions, including several for targeted specific genetic anomalies (see Part 1 of this series). While FDA published draft guidance on biosimilar product development in the federal register in 2012, there were no "firsts" approved under these rules in the U.S. last year.1 By comparison, at least 14 biosimilars are approved for use in the European Union.2 Despite the name similarities, FDA is deliberate in pointing out that two 2012 approvals, tbo-filgastim and ziv-aflibercept (see Table 70-2) were not approved under the biosimilar rules. On a different note, three previously marketed, unapproved pancreatic enzyme products were licensed in 2012, doubling the number of products marketed to improve digestion in patients with pancreatic insufficiency. FDA affirmation of these previously "marketed, unapproved" drugs established the good manufacturing practices necessary to assure the batch-to-batch reliability of their pharmacological activity.3 On the medical devices forefront, FDA extended a biological license for BIO-SEAL as a lung biopsy tract plug system to reduce the risk of a collapsed lung following percutaneous transthoracic needle biopsies. This approval represents an innovative use of an existing device that contains a dyed gel in a delivery system designed to attach to the biopsy needle following tissue extraction. The gel is injected into the empty space in the biopsy tract and expands as it rehydrates to form a seal that prevents air from leaking out of the lung. The seal is visible on imaging to expedite follow-on surgical procedures that may be indicated by the results of the biopsy. The gel is absorbed by the body as the puncture site heals. Other 2012 noteworthy FDA regulatory activities are assembled and characterized below. Table 70-3 lists established drugs that were extended for a new indication or significantly reformulated in 2012.

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Table 70-2.New Drugs Licensed in 2012 with Pharmacological Mechanisms Similar to Previously Approved Drugs

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