Glenmark receives US FDA approval for Icatibant Injection
Glenmark receives US FDA approval for Icatibant Injection
25 May 2021 | News The injection will be manufactured in their North American manufacturing facility based in Monroe, North Carolina
Glenmark Pharmaceuticals (Glenmark) has received final approval by the United States Food & Drug Administration (US FDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, the generic version of Firazyr 1 Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, of Shire Human Genetic Therapies. This marks Glenmark s first synthetic decapeptide injectable approval and will be manufactured in their North American manufacturing facility based in Monroe, North Carolina.
Domestic equity barometers were trading higher in early afternoon trade. The moderation in daily new COVID-19 cases in India improved risk sentiments. The Nifty index hovered tad above 15,200 mark.
At 12:20 IST, the barometer index, the S&P BSE Sensex, rose 140.06 points or 0.28% at 50,680.54. The Nifty 50 index gained 32.50 points or 0.21% at 15,207.80.
In the broader market, the S&P BSE Mid-Cap index rose 0.98% while the S&P BSE Small-Cap index gained 0.82%.
The market breadth was strong. On the BSE, 1,909 shares rose and 1,108 shares fell. A total of 184 shares were unchanged.
Derivatives:
The NSE s India VIX, a gauge of market s expectation of volatility over the near term, rose 0.64% to 19.2025. The Nifty 27 May 2021 futures were trading at 15,212.35, at a premium of 4.55 points compared with the spot at 15,207.80.
Equity indices ended with small gains on Monday led by firmness in banks stocks. The Nifty closed below the 15,200 mark after trading above that level for most part of the session. The moderation in daily new COVID-19 cases in India improved risk sentiments. Barring FMCG and metal, all the sectoral indices on the NSE ended in the green.
As per the provisional closing data, the barometer index, the S&P BSE Sensex, rose 111.42 points or 0.22% at 50,651.13. The Nifty 50 index gained 22.40 points or 0.15% at 15,197.70.
The broader market outperformed the benchmark indices. The S&P BSE Mid-Cap index surged 0.86% while the S&P BSE Small-Cap index gained 0.7%.
Equity indices ended with small gains on Monday, supported by firmness in banks stocks. The Nifty closed below the 15,200 mark after trading above that level for most part of the session. The moderation in daily new COVID-19 cases in India improved risk sentiments. Barring FMCG and metal, all the sectoral indices on the NSE ended in the green.
The barometer index, the S&P BSE Sensex, rose 111.42 points or 0.22% at 50,651.90. The Nifty 50 index gained 22.40 points or 0.15% at 15,197.70.
State Bank of India (up 2.73%), Larsen & Toubro (up 1.74%) and Axis Bank (up 1.40%) supported the indices.
The broader market outperformed the benchmark indices. The BSE Mid-Cap index added 0.86% and the BSE Small-Cap index rose 0.70%.
Glenmark Pharmaceuticals rose 1.23% to Rs 614.80 after the drug maker said it received ANDA approval for icatibant injection, 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe.Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (USFDA) for icatibant injection. The product is the generic version of Firazyr injection of Shire Human Genetic Therapies.
This marks Glenmark s first synthetic decapeptide injectable approval and will be manufactured in their North American manufacturing facility based in Monroe, North Carolina.
Firazyr is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. According to IQVIA sales data for the 12 month period ending March 2021, the Firazyr injection achieved annual sales of approximately $223.4 million.