Pharmaceutical company Cipla Limited (BSE:500087) (NSE:CIPLA EQ) disclosed on Friday the receipt of US Food and Drug Administration final approval for its Abbreviated New Drug Application (ANDA) for Esomeprazole for Oral Suspension in 10mg, 20mg and 40mg .
The company stated that it is the first to file for Esomeprazole for Oral Suspension the 10mg strength.
Cipla added that the Esomeprazole for Oral Suspension 10mg, 20mg and 40mg is AB-rated generic therapeutic equivalent version of AstraZeneca Pharmaceutical's Nexium. The product is available for shipping immediately.
Nexium is a proton pump inhibitor indicated for treatment of gastroesophageal reflux disease (GERD), risk reduction of NSAID-associated gastric ulcer, H. pylori eradication to reduce the risk of duodenal ulcer recurrence as well as pathological hypersecretory conditions, including Zollinger-Ellison syndrome, revealed the company.
According to IQVIA (IMS Health), Nexium and its generic equivalents had US sales of approximately USD70m for the 12-month period ending November 2019.
EirGenix signs second global exclusive licensing deal with Sandoz
Padagis invests USD36m to expand manufacturing in Minneapolis
Newbury Pharmaceuticals gains Danish approval for generic ivermectin cream
Esperion settles with Dr. Reddy's Laboratories on NEXLETOL and NEXLIZET generics
Mint Pharmaceuticals forms distribution partnership with Bayer Canada
Padagis collaborates with The Naloxone Project to address opioid overdose crisis
Zentiva announces sale from Advent to GTCR
Biocon's first US manufacturing facility inaugurated in Cranbury, New Jersey
Amneal's risperidone extended-release injectable suspension approved by US FDA
First FDA acceptance to waive clinical efficacy studies for monoclonal antibody biosimilars
Coya Therapeutics wins FDA clearance to advance COYA 302 into Phase 2 ALS trial
Viatris' generic iron sucrose injection gains US FDA approval
Newbury Pharmaceuticals gains Finnish approval for generic melatonin
CivicaScript to distribute biosimilar for chronic inflammatory conditions