Pharmaceutical company Cipla Limited (BSE:500087) (NSE:CIPLA EQ) reported on Monday the receipt of the final approval for its Abbreviated New Drug Application (ANDA) for Icatibant Injectable 30mg/3ml from the US Food and Drug Administration (FDA).
According to the company, the Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
The Icatibant Injectable pre-filled syringe in 30mg/3ml is an AP-rated generic version of Shire's Firazyr.
For the 12-month period ending May 2020, Firazyr and its generic equivalents had US sales of approximately USD270m based on data from IQVIA (IMS Health).
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