FDA Approves Expanded Indication For Kalbitor, Lupin’s Generic of Actos

The Food and Drug Administration recently approved an expanded indication for Kalbitor, another generic version of Actos and an eye drug.

Dyax Corp. April 3 said that the FDA approved an expansion of the indication for Kalbitor (ecallantide), a peptide inhibitor of plasma kallikrein used in treating acute hereditary angioedema (HAE) attacks, to include patients 12 years of age and older.

Kalbitor was approved in 2009 for treating patients ages 16 and older who experience HAE attacks 7 PLIR 1383, 12/4/09.

With this approval, Kalbitor is the only subcutaneous therapy available to treat acute attacks of HAE in patients ...