505(b)(2) archaeology

Novartis AG has fired back against rival Pfizer Inc. in the battle over FDA's authority to approve follow-on versions of biologics that are regulated as drugs, pointing out that the agency approved a recombinant biologic six years ago under section 505(b)(2) of the Food, Drug and Cosmetic Act.

Sandoz, the generics subsidiary of Novartis (NVS; SWX:NOVN, Basel, Switzerland), has filed an application under section 505(b)(2) for approval of Omnitrope (Omnitrop in Europe), a human growth hormone (hGH) product. ...