Article

India’s Injectable Company Got FDA Nod for Anti-Infective Drug

377 views

claris lifesciences logoAhmedabad based Claris Lifesciences, a leading sterile injectable company got US FDA approval for its generic tobramycin injection used for the treatment of bacterial infections.

This buzz spiked high the company in share market to reach its highest point in last 11 months.

claris shares in 2016

Figure 1. Shares price of Claris Lifesciences surges on USFDA nod for Tobramycin injection (photo credit: economictimes.indiatimes.com).

Claris received the approval of abbreviated new drug application (ANDA) for the tobramycin injection of 80 mg/2mL and 1200 mg/30mL multiple dose vials in the US market.

tobramycin structure

Tobramycin

This approval marks the 14th ANDA approval of Claris and 24 ANDAs are under the process of approval. The approved ANDAs will be required to address the estimated market of above $300 million.

The company expects more product approvals this year which will definitely help Claris to gain strong foothold in the US market. The estimated market size in the US is $6 million and currently the product falls in the shortage list of US Food and Drug Administration (FDA).

The anti-infective drug, tobramycin injection is an aminoglycoside antibiotic used to treat several types of bacterial infections. The aminoglycosides have high affinity for specific portions of RNAs. Therefore, tobramycin binds to the specific binding sites of the RNAs in the bacteria and prevents its translation into protein and finally leading to cell death.

Tobramycin is derived from Streptomyces tenebrarius and is used to treat various bacterial infections like meningitis and other infections of blood, abdomen, lungs, skin, joints, bones and urinary tract.

Here is the nice video explaining the molecular mechanism of aminoglycosides (credit: Peter Thomas).

Featured Image Credit: Reception at Corporate Headquarter (Claris Lifesciences).

Leave a reply

Your email address will not be published. Required fields are marked *