Breckenridge Pharmaceutical Inc, a subsidiary of Towa Pharmaceutical, announced on Thursday that it has received final approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Apixaban Tablets (generic for Eliquis).
Towa Pharmaceutical Europe, SL produced the product at its Martorelles, Spain manufacturing facility. According to industry sales data, Eliquis generated annual sales of USD14 billion during the twelve months ending May 2021.
The company has received a license under confidential terms allowing Breckenridge to introduce generic Apixaban Tablets under its ANDA at a later date.
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
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