BDR Pharma gets CDSCO panel nod to market antineoplastic drug Azacitidine
New Delhi: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has shown a green flag to BDR Pharmaceuticals for the manufacturing and marketing of the antineoplastic drug Azacitidine.
This approval came after BDR Pharmaceuticals presented their proposal for manufacturing and marketing Azacitidine tablets 200mg, requesting a bioavailability/bioequivalence study (BA/BE) and clinical trial (CT) study waiver.
The firm further presented their proposal along with the dissolution profile and BCS data of the applied drug products, i.e., Azacitidine Tablets 200mg, before the committee.
Azacitidine is a pyrimidine nucleoside analogue used to treat certain subtypes of myelodysplastic syndrome. Myelodysplastic syndrome (MDS) is a type of malignancy in which immature blood cells in the bone marrow do not mature and do not become healthy blood cells.
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Azacitidine is incorporated into DNA, where it reversibly inhibits DNA methyltransferase, thereby blocking DNA methylation. Hypomethylation of DNA by azacitidine may activate tumor suppressor genes silenced by hypermethylation, resulting in an antitumor effect. This agent is also incorporated into RNA, thereby disrupting normal RNA function and impairing tRNA cytosine-5-methyltransferase activity.
In India, some popular brands of Azacitidine 100mg include Sun Pharma's Azzure 100mg Injection, Glenmark's Azactiv 100mg Injection, and Dr. Reddy's Azacytin 100mg Injection.
At a recent SEC meeting for Oncology & Haematology, the committee extensively reviewed BDR Pharma's proposal for manufacturing and marketing Azacitidine tablets 200mg.
In this regard, the committee noted that Azacitidine Tablet 300mg is approved in India for the applied indication.
After detailed deliberation, the committee recommended the grant of permission for the manufacture and marketing of Azacitidine Tablets 200 mg for the approved indication.
