Wockhardt gets USFDA approval for cancer drug

Wockhardt gets USFDA approval for cancer drug

On April 10, 2019, the Biotechnology and Pharmaceutical major Wockhardt Ltd received US Food and Drug Administration (USFDA) approval for an ANDA of 50 mg injection of Decitabine injection.

Decitabine injection is an anti-cancer drug that works as a Nucleic Acid Synthesis Inhibitor. It is a chemotherapy drug to treat Myelodysplastic syndrome (MSD). MSD is a group of cancer in which immature blood cells in the bone marrow do not mature and hence they done transform into healthy blood cells if not treated can progress to leukaemia.

Further, Decitabine injection of Wockhardt is a generic version of Dacogen by Otsuka Pharmaceutical which is marketed in the US. According to IQVIA, the product sale of this drug in February 2019 was of USD 120 million.

Moreover, this is the third oncology drug approval by USFDA to Wockhardt in 3 months. The company will launch this drug in the US after a short duration. Further, this drug is manufactured at the contract manufacturing facility of the company based near Hyderabad India.


Other Oncology approvals by USFDA:

On March 1, 2019, Wockhardt received USFDA approval for ANDA drug of 250 mg tablet of Abiraterone acetate. It is used to treat prostate cancer. Further, Abiraterone acetate of Wockhardt is a generic version of Zytiga of Johnson & Johnson that is marketed in the US and other countries. According to IQVIA sales data of December 2018, this product had sales of USD 1.26 billion in the US. Abiraterone drug will be used to treat men with prostate cancer spread in other parts of the body.

On January 21, 2019, Wockhardt Ltd received another USFDA approval for 100 mg and 400 mg tablets imatinib Mesylate tablets. It is used to treat various types of cancer and tumours. Imatinib Mesylate tablets of Workhardt are a generic version of Gleevec from Novartis that is marketed in the US and other countries. Furthermore, Imatinib Mesylate stops the cancer cells from growing and it is indicated for the treatment of cancers line Gastro-Intestinal tumour and Leukemia. As per IMS MAT 1118, the product has sales of USD 707 million in the US.


Company Information:

The global Biotech and pharmaceutical major Wockhardt Ltd have a presence in 27 nationalities. The company is spread in countries like the USA, UK, Switzerland, Mexico, Russia, France, India and others. In addition to this, the company has its manufacturing & research facilities in India, USA, UK and Ireland. Also, Workhardt is the only company across the globe where the USFDA has given Qualified Infectious Disease Programme (QIDP) status for 5 Anti-bacterial discovery programme. Out of these 5, two of them are Gram-negative and the remaining three are Gram-positive against untreatable ‘Superbugs’.

Stock Movement:

Wockhardt Ltd on April 11, 2019, at 1 PM the stock surged around 2% at Rs. 450.50 a piece on NSE. On an Intraday basis, the stock jumped up by 3.48% at Rs. 457.50 per share.



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