Last Updated on October 2, 2024 by The Health Master
Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tiotropium Bromide Inhalation Powder, 18 mcg/capsule.
This drug is a generic equivalent of Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder), 18 mcg/capsule of Boehringer Ingelheim Pharmaceuticals.
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 USFDA. 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 US.”
“This is an important milestone in our journey of building our respiratory franchise globally,” said Vinita Gupta, CEO, Lupin.
Tiotropium Bromide Inhalation Powder (RLD Spiriva) had estimated annual sales of $1,264 million in the US. (IQVIA MAT Mar 2023).
USFDA gives approval for generic acne-treating drug
USFDA gives final nod for Varenicline Tablets
USFDA gives approval for Levetiracetam Tablets
USFDA gives approval for Metoprolol Succinate ER Tablets
Govt contemplates divesting Stake in Pharma Sector PSUs
India plans to establish Self-Regulatory Body for Pharma Industry
Advantages and Integration of Pharma Sahi Daam App: Karnataka
Govt Job: For the post of Drugs Inspector under Public Service Commission
Zydus Lifesciences gets USFDA nod for generic acne-treating drug
German pharma major Bayer stops business in Pakistan: Report
Importance of Quality and Regulations in the Pharma Industry
Upcoming events: Pharma, Cosmetics, Homoeopathy & Medical Devices
PCI: Pharmacy is an independent profession, not paramedical course
209 Pharma companies under Govt lens over violations
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: