FDA Approvals, In Brief
FDA’s active week included clearing expanded indications for Novartis’s Afinitor Disperz and Janssen’s Nucynta ER.
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After FDA approval of Linzess, the commercial challenge of competing with over-the-counter laxatives begins. Ironwood is well-versed on the success story of proton pump inhibitors and the mixed record of withdrawn constipation/IBS drug Zelnorm when it comes to introducing a branded drug into the market.
Teva is the first company to get FDA approval of a version of Amgen’s Neupogen; one biosimilar expert questions why Teva did not switch its BLA to a biosimilar application when that pathway became available.