Lupin gets US FDA approval for key respiratory drug Spiriva generic; stock jumps over 5%
This product will be manufactured at Lupin’s Pithampur facility in India
- Jun 21, 2023,
- Updated Jun 21, 2023 2:11 PM IST
Pharma major Lupin Ltd's share price jumped over 5% on Wednesday after it announced that it has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Tiotropium Bromide Inhalation Powder, 18 mcg/capsule, a generic equivalent of Spiriva® HandiHaler®.
At 1400 hours on Wednesday, Lupin's scrip on BSE was trading 5.3% higher at Rs 874.35. This product will be manufactured at Lupin’s Pithampur facility in India.
“We are delighted to receive the final approval for generic Spiriva® HandiHaler from the US FDA. This builds on our commitment to serving unmet needs for our patients across the world. This is the first generic approval for Spiriva® HandiHaler in the US, and is also the first DPI approval from India for the U.S. This is an important milestone in our journey of building our respiratory franchise globally,” said Vinita Gupta, CEO, Lupin.
Tiotropium Bromide Inhalation Powder (Spiriva® HandiHaler®) had estimated annual sales of $1.26 billion in the US as of March 2023.
Pharma major Lupin Ltd's share price jumped over 5% on Wednesday after it announced that it has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Tiotropium Bromide Inhalation Powder, 18 mcg/capsule, a generic equivalent of Spiriva® HandiHaler®.
At 1400 hours on Wednesday, Lupin's scrip on BSE was trading 5.3% higher at Rs 874.35. This product will be manufactured at Lupin’s Pithampur facility in India.
“We are delighted to receive the final approval for generic Spiriva® HandiHaler from the US FDA. This builds on our commitment to serving unmet needs for our patients across the world. This is the first generic approval for Spiriva® HandiHaler in the US, and is also the first DPI approval from India for the U.S. This is an important milestone in our journey of building our respiratory franchise globally,” said Vinita Gupta, CEO, Lupin.
Tiotropium Bromide Inhalation Powder (Spiriva® HandiHaler®) had estimated annual sales of $1.26 billion in the US as of March 2023.