Panacea Biotec gets USFDA nod for chemotherapy drug Azacitidine

Azacitidine is a chemotherapy drug used to treat myelodysplastic syndromes (MDS) with annual sales of about USD 110 million in US markets as per IQVIA data as of December 2018.

New Delhi: Indian research-based pharmaceutical and health management company Panacea Biotec's Oncology Parenteral Formulation Facility at Baddi, Himachal Pradesh has recently received United States Food & Drug Administration (USFDA) approval for manufacture and supply of Azacitidine Injection, 100 mg/vial, for the US market.

Azacitidine is a chemotherapy drug used to treat myelodysplastic syndromes (MDS) with annual sales of about USD 110 million in US markets as per IQVIA data as of December 2018.

"Panacea Biotec's state-of-the-art pharmaceutical formulation facility at Baddi is already approved by the National Regulatory Authority (NRA) of India and USFDA for other oral solids and injectable products," said Panacea in a filing.

Prior to this, the company entered into a tripartite agreement with Natco Pharma Ltd. ("Natco") and Breckenridge Pharmaceutical Inc. USA ("Breckenridge") for manufacturing and supply thereof for the US market under Breckenridge's existing approved ANDA for Azacitidine for Injection 100mg/vial, the generic equivalent of Vidaza, marketed by Celgene Corp, US.

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The supplemental abbreviated new drug application (ANDA) submitted by Natco as "Prior Approval Supplement" has recently been approved by the USFDA.

Panacea Drugs Pvt. Ltd. was set up in the year 1984 and got listed in 1995 as Panacea Biotec Ltd. The company is involved in research, manufacturing, and marketing of pharmaceutical formulations, vaccines, and natural products.