AstraZeneca Pharma India Limited has received permission to import pharmaceutical formulations of new drug for sale or for distribution in Form CT-20 from Central Drugs Standard Control Organisation for Palivizumab (Synagis) solution for injection 100 mg/ml (r-DNA origin) (50mg/0.5mL & 100 mg/mL presentations in single-dose vials administered through intramuscular route).
Through this approval, Palivizumab (Synagis) is indicated for the prevention of serious lower respiratory tract disease requiring hospitalization caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease:
- Infants born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season.
- Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia (BPD) within the last 6 months.
- Children less than 2 years of age and with haemodynamically significant congenital heart disease (CHD).
The receipt of this permission paves way for the launch of Palivizumab (Synagis) solution for Injection 100 mg/ml (50mg/0.5mL & 100 mg/mL presentations in single-dose vials administered through intramuscular route) in India for the specified indication, subject to the receipt of related statutory approvals, if any.
Shares of AstraZeneca Pharma India Limited was last trading in BSE at Rs. 4504.10 as compared to the previous close of Rs. 4460.50. The total number of shares traded during the day was 313 in over 113 trades.
The stock hit an intraday high of Rs. 4511.40 and intraday low of 4431.95. The net turnover during the day was Rs. 1397659.00.