- On June 21, 2023, Lupin Pharmaceuticals announced that it has received approval from the US Food and Drug Administration (FDA) for its Tiotropium Dry Powder Inhaler. This is the first generic version of Spiriva HandiHaler, a long-acting bronchodilator that is used to treat chronic obstructive pulmonary disease (COPD).
- COPD is a serious lung disease that affects millions of people worldwide. It is characterized by a narrowing of the airways, which makes it difficult to breathe. Tiotropium works by relaxing the muscles in the airways, making it easier to breathe.
- The approval of Lupin’s Tiotropium Dry Powder Inhaler will provide patients with a more affordable option for treating COPD. It will also help to increase competition in the market, which could lead to lower prices for all patients.
- Lupin plans to launch its Tiotropium Dry Powder Inhaler in the US in the coming months. The company is also working on developing other generic versions of respiratory drugs.
Here are some additional details about the approval:
- The approval was based on data from a clinical trial that showed that Lupin’s Tiotropium Dry Powder Inhaler was as effective as Spiriva HandiHaler in improving lung function in patients with COPD.
- The approval covers the 18 mcg dose of Tiotropium Dry Powder Inhaler. Lupin is also planning to submit an application for the 10 mcg dose.
- The approval of Lupin’s Tiotropium Dry Powder Inhaler is a significant milestone for the company. It is the first generic version of Spiriva HandiHaler to be approved by the FDA.