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Dr. Reddy's Azacitidine for injection gets FDA nod

18 September 2013 | News | By BioSpectrum Bureau

The company has said that the launch of the product in the US market is scheduled in the near term

The company has said that the launch of the product in the US market is scheduled in the near term

Singapore: The US FDA has granted approval for the launch of Dr. Reddy's Laboratories's cancer drug Azacitidine for injection. This generic version of Vidaza is used in the treatment of myelodysplastic syndrome (MDS), a disease affecting bone marrow that can turn into a fast-growing cancer of bone marrow cells.

The company has said that the launch of the product in the US market is scheduled in the near term and will be made available as DRL's Azacitidine for Injection 100 mg/vial in single-use vials.

As per industry data, Vidaza brand is said to have had clocked sales of approximately $378.5 million for the 12 months ending July 2013 in the US market.

Only last year, the company entered into an alliance with Merck Serono, a division of Merck, Darmstadt, Germany, to co-develop and globally commercialize a portfolio of biosimilar compounds in oncology, primarily focused on monoclonal antibodies (MAbs).

In March this year the company also launched Zoledronic acid injection in the US market following approval by the US FDA. The injection is a copy of Novartis Zometa, a drug used to strengthen bones in cancer patients.


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