AstraZeneca India (AstraZeneca Pharma India Limited), a biopharmaceutical company, on Monday received government approval for Dapagliflozin (Forxiga) to treat patients for heart failure. This is the first anti-diabetic drug approved for the treatment of heart failure (HF).
It is also the first drug proven to reduce the risk of cardiovascular death and hospitalisation. The approval is based on results from the DAPA-HF study, which proved that Forxiga, in addition to standard of care, reduced risk of cardiovascular death or the worsening of heart failure by 26 per cent.
About one-fourth patients in the study were from regions in Asia, including India, a statement issued on Monday said.
Mylan gets DCGI approval for remdesivir 100 mg/vial for emergency use for Covid patients
Pune: Mylan N V, a global pharmaceutical firm, on Monday said the Drug Controller General of India (DCGI) has approved its remdesivir 100 mg/vial for restricted emergency use in India. This is part of the DCGI’s accelerated approval process to address urgent needs amid the Covid-19 pandemic.
The drug has been approved for treatment of suspected or laboratory confirmed cases of Covid-19 in adults and children hospitalised with severe presentations of the disease.
The drug will be launched under the brand name DESREM in India, and will be available to patients in July for Rs 4,800. This price is over 80 per cent less than that at which the branded version of this product will be available to governments in developed countries. ENS
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