USA – Zydus Cadila, a pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration to market Decitabine injection, which is used to treat certain types of cancer, in the United States.
According to Zydus Cadila, the company has received final approval from the US Food and Drug Administration (USFDA) for Decitabine for Injection in the strength of 50 mg/vial single-dose vial.
Zydus Pharmaceuticals USA Inc, a subsidiary of the company, has been granted competitive generic therapy (CGT) designation for the product, making it eligible for 180 days of exclusivity.
The drug is produced at the Zydus group’s injection manufacturing facility in Ahmedabad and will be commercially available in the United States immediately.
Decitabine is a chemotherapy drug that is used to treat myelodysplastic syndromes and certain types of leukemia and lymphoma by slowing or stopping cancer cell growth.
This FDA approval of Decitabine Nelarabine Injection demonstrates our long-term commitment to patients by providing them with access to low-cost generics.
“This approval builds on our proven track record of successfully commercializing and gaining meaningful market share in complex generics products,” said Sharvil Patel, Managing Director of Cadila Healthcare.
The Zydus group now has 326 approvals and has filed over 400 abbreviated new drug applications (ANDAs) since the filing process began in 2003-04, according to the company.
Meanwhile, Germany’s BioNTech has been awarded fast track designation by U.S. drugs regulators for the speedy review of a novel skin cancer therapy, which is based on RNA technology similar to the one that underpins its COVID-19 vaccine.
The U.S. Food and Drug Administration (FDA) granted the fast track status to the BNT111 infusion, which is designed to instruct the body to produce four proteins that are characteristic of melanoma cells and trigger an immune response against those cancer cells in the body.
“With the Fast Track status and FDA support, we aim to expedite the further development of the BNT111 program to provide a new therapeutic option for patients with life-threatening, hard-to-treat melanoma,” said zlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech.
The vaccine candidate is currently being investigated in patients with anti-PD-1-refractory, relapsed unresectable stage three or four melanoma.