Orchid Pharma Gets USFDA Nod, To Market Drug In US Soon

CHENNAI, (IANS) – Vertically integrated pharma player Orchid Pharma Ltd said on February 23 that it will launch its Enmetazobactam drug in the US in the next couple of quarters.

The company has received approval from the United States Food and Drug Administration (USFDA) for its invention Enmetaobactam, a Beta Lactamase Inhibitor.

According to the company, the USFDA approval paves the way for the introduction of Enmetazobactam in the US, the largest pharmaceutical market in the world.

The product is expected to be launched within the next couple of quarters in the US market.

This development comes in close succession to the recent recommendation for approval by the European Medicines Agency.

This New Drug Approval 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, 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 Pharma and then out-licensed to Allecra Therapeutics for further development.

Dhanuka Group acquired Orchid Pharma under Insolvency and Bankruptcy Code in  2020.