Panacea Biotec receives USFDA approval for manufacture, supply of Azacitidine for US market

MUMBAI, May 22: Pharma Major, Panacea Biotec said that company’s Oncology Parenteral Formulation Facility at Baddi, Himachal Pradesh has received United States Food & Drug Administration (USFDA) approval for manufacture and supply of Azacitidine Injection, 100 mg/vial, for the US market.
Panacea Biotec’s state-of-the-art pharmaceutical formulation facility at Baddi is already approved by National Regulatory Authority (NRA) of India and USFDA for other oral solids and injectable products, company said in a filing with BSE.
Panacea Biotec had earlier entered into a tripartite agreement with Natco Pharma Ltd and Breckenridge Pharmaceutical Inc. USA for manufacturing and supply thereof for the US market under Breckenridge’s existing approved ANDA for Azacitidine for Injection 100mg/vial, generic equivalent of Vidaza, marketed by Celgene Corp, US.
The supplemental abbreviated new drug application (ANDA) submitted by Natco as “Prior Approval Supplement” has recently been approved by the USFDA.
Azacitidine is a chemotherapy drug used to treat myelodysplastic syndromes (MDS) with annual sales of about USD 110 Mn in US markets as per IQVIA data as of December, 2018.