Orchid Pharma gets USFDA approval for Exblifep

Orchid Pharma has received approval by the United States Food and Drug Administration (USFDA) for its novel invention, ‘Enmetazobactam’. This development comes in close succession to the recent recommendation for approval by the European Medicines Agency (EMA). Enmetazobactam is the first completely invented-in-India Beta Lactamase Inhibitor.

This USFDA approval paves the way for the introduction of Enmetazobactam in the US, the largest pharma market in the world. The product is expected to be launched within the next couple of quarters in the US market.

This New Drug Approval (NDA) allows the use of Exblifep (Cefepime and Enmetazobactam) as an injection for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, and Enterobacter cloacae complex.

Enmetazobactam was invented in India by Orchid and then out licensed to Allecra Therapeutics for further development.