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First Indian discovered antibiotic gets FDA approval, took 16 years to reach market

 

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First Indian discovered antibiotic gets FDA approval, took 16 years to reach market

Orchid Pharma, based in Chennai, India, 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 United States, 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 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.

Orchid is the first company from India, ever to have invented a product which has received a New Drug Approval (NDA) from USFDA. It is a significant development in addressing the global need for affordable and efficacious drugs to combat Anti-Microbial Resistance (AMR).


On this occasion, Mr. Manish Dhanuka, Managing Director - Orchid Pharma, said, “While EMA recommendation for grant of marketing authorization last month was a big achievement, the USFDA approval reinforces Orchid’s position on the safety of the drug and its innate need in the times of increasing Antimicrobial resistance.”

“First discovered in 2008, it has taken 16 years of pain staking work to get the product to market. During this time countless tests were done to establish its safety and efficacy and generate data for submission to regulatory authorities worldwide.” he added.


Enmetazobactam was invented in India by Orchid and then out licensed to Allecra Therapeutics for further development. With the potential to save thousands of lives globally, this approval by USFDA is a testament to Indian ingenuity. It is also a matter of great pride that as the pharmacy of the world, India has finally developed a new drug for the first time.