FDA review of Salix drug pushed back to July

Salix Pharmaceuticals announced Monday that federal regulators expect to have reviewed the company's application for the drug Ruconest by July 16.

The Food and Drug Aministration had originally expected to complete its review in April.

Salix is developing the drug, a treatment for acute angioedema attacks, along with the Dutch drugmaker Pharming Group NV. Angioedema is a swelling just under the skin that is similar to hives.

Ruconest was one of the drugs being developed by the specialty drug company Santarus, which Salix acquired for $2.6 billion earlier this year. The deal gave Salix a portfolio of 22 drugs with annual revenue of nearly $1.35 billion.

Santarus also had several drugs in various stages of regulatory review, including a treatment for travelers' diarrhea and a monoclonal antibody. Salix and Pharming Group have submitted a Biologics License Application for Ruconest with the Food and Drug Administration.

Salix also recently announced that the FDA had accepted its new drug application for Budesonide, a rectal foam used to treat patients with ulcerative colitis. The FDA expects to issue a ruling on that application on Sept. 15.

Read more here: http://www.newsobserver.com/2014/02/24/3650398/fda-review-of-salix-drug-pushed.html#storylink=cpy

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