HQ Team
January 4, 2023: Aurobindo Pharma announced that its fully-owned subsidiary, Eugia Pharma Specialities, received final approval from FDA to make and market Azacitidine injection for cancer treatment.
The 100 mg single-dose vial is the bioequivalent and therapeutically equivalent to the reference listed drug, Vidaza injection, of Bristol-Myers Squibb Company, according to a BSE filing.
Aurobindo expects to unveil the injection this month. The approved product has an estimated market size of about $ 46 million for the twelve months ending November 2022, according to IQVIA, a research company.
The injection is the 153rd ANDA, including ten tentative approvals received) out of Eugia Pharma Speciality Group facilities, which manufactures oral and sterile specialty products.
An Abbreviated New Drug Application is an application for a US generic drug approval for an existing licensed medication or approved drug.
Azacitidine
The Azacitidine injection is used to treat myelodysplastic syndromes, a group of cancers in which immature blood cells in the bone marrow do not mature or become healthy blood cells.
In a healthy person, the bone marrow makes blood stem cells (immature cells) that become mature blood cells over time.
Some types have no known cause, while others occur in response to cancer treatments or chemical exposure. Symptoms may include shortness of breath, fatigue, easy bruising and paleness.
The myelodysplastic syndrome may progress to leukaemia. Transfusions and medication help manage symptoms. Medication or bone marrow transplants may lessen transfusion needs and slow or prevent the progression to leukaemia.
Refractory anaemia
According to Aurobindo, the injection can also help with refractory anaemia and chronic myelomonocytic leukemia, apart from treating adult patients with myelodysplastic syndrome.
Aurobindo Pharma is a global pharmaceutical company headquartered in Hyderabad, India.
