Cipla gets USFDA nod for Inhalation product

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

36
Medicine
Picture: Pixabay

Last Updated on June 26, 2021 by The Health Master

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 (USFDA), 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.

Alkem gets two observations from USFDA for USA plant

Lupin gets USFDA nod for treatment of Kidney patient

Aleor gets USFDA nod for Testosterone Topical Solution

Avenue Therapeutics gets complete response letter from USFDA for IV Tramadol

Natco gets USFDA nod for Carfilzomib Injection

Lupin gets warning letter from USFDA for Somerset facility

IPC to sensitize stakeholders on manufacturing of Quality Drugs

J Mitra and Company launches C-19 Microlisa Elisa Test kit

Mankind launches drug to treat Diabetes, Heart failure

Dr. Reddy’s Labs launches Icosapent Ethyl Capsules

Cadila Pharma launches Posaconazole to treat fungal diseases

European Commission approves Empagliflozin to treat heart failure

Telegram
WhatsApp
Facebook
LinkedIn
Google-news

Enter your email address:

Delivered by FeedBurner