Categories: Uncategorized

USFDA nod to Cipla’s inhalation product

Cipla yesterday said that it has received final approval from the US health regulator for Arformoterol Tartrate Inhalation Solution, used to treat conditions like chronic bronchitis and emphysema, in the US market.

The approved product is a generic version of Sunovion Pharmaceuticals Inc’s Brovana.

The company has received final approval for its Abbreviated New Drug Application (ANDA) for Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL from the United States Food and Drug Administration (FDA), Cipla said in a regulatory filing.

Brovana is used in the maintenance treatment of bronchoconstriction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema.

Quoting IQVIA (IMS Health) data, Cipla said Brovana had sales of approximately $438 million for the 12-month period ending April 2021.

The product is available for shipping immediately, it added.

Medically Speaking Team

Recent Posts

Cold Hands & Feet in Winter: Causes, Remedies, and Prevention Tips

https://youtu.be/LZi8Jn0tAA8?si=bpMPudQxl1LUdgXN Cold Hands & Feet in Winter: Causes, Remedies, and Prevention Tips Winter can be…

51 mins ago

Dysautonomia: The Silent Illness Affecting Millions Globally

Dysautonomia: The Silent Illness Impacting Millions of People Worldwide Dysautonomia is an umbrella term used…

2 days ago

Chyawanprash: Your Ayurvedic Shield Against Cough & Cold

https://youtu.be/mdl3AFFFcuk?si=i2cYzTX7WJ-z6wRp Does Chyawanprash Help in Cough & Cold? Exploring Its Benefits and Efficacy Chyawanprash, a…

2 days ago

Why Winter Morning Walks (7-9 AM) Are Perfect for Your Health

Walk In Winter: In winter, the time from 7:00 AM to 9:00 AM is considered…

2 days ago

Does Maida Stick to Your Gut? Debunking Myths and Health Risks

Does Maida Stick To Your Gut Lining: In this article, we debunk the common myth…

2 days ago

Think Twice Before Heating Packaged Milk: Hidden Risks You Should Know!

https://youtu.be/4NTKSfNf1TM?si=Y4xkEOKDUvqpIEZt The Disadvantages of Heating Packaged Milk Milk is a staple in many households and…

2 days ago