Homegrown pharmaceutical firm Lupin Ltd on Thursday said it has received a Complete Response Letter (CRL) from the US Food and Drug
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Lupin has emerged as the first generic player to get the USFDA nod to sell the billion-dollar respiratory drug Spiriva generic (gSpiriva) in the United States
Indian pharmaceutical company Lupin on June 21 received the much-awaited final approval for its generic version of Boehringer Ingelheim's Spiriva Handihaler
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Published on: Jun 21, 2023, 2:11 PM IST Posted by: Jamma of Lupin Tiotropium Bromide Inhalation Powder Compared to SPIRIVA® HANDIHALER® and Placebo in Patients with COPD including a 12-Week Open-Label Extension to Assess Inhaler Robustness
Lupin has received the Food and Drug Administration’s permission for Tiotropium Bromide Inhalation Powder, 18 mcg/capsule, which is a generic of Boehringer Ingelheim’s Spiriva HandiHaler
Do not use it to treat a sudden asthma attack or COPD flare-up
Lupin has pushed the US launch for a generic to Boehringer’s blockbuster COPD drug Spiriva to September as FDA action is now expected “latest by August”
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For more information about tiotropium bromide inhalation powder, visit our website at www
Spiriva (tiotropium) is a brand-name drug that's used to treat COPD and asthma
Litigation was initiated within the statutory 45-day period against Lupin for Lupin Pharmaceuticals, Inc
The product is seen as a major element of Lupin’s respiratory franchise and a key contributor to the Indian firm’s fortunes this year
Lupin is also consistently gaining market share for Spiriva, which is at 24 percent after 18 weeks of launch
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41% of reviewers reported a positive effect, while 33% reported a negative Our FY24 margin presumes Spiriva approval, and this continues to be a key catalyst
32%
Additionally, the FDA has approved several generic products developed by Lupin
Ramesh Swaminathan, ED, Global CFO, Lupin with CNBC International – Q1 FY 24 Earnings – 8 Feb 2024
(Spiriva HandiHaler) had a market value of approximately $1