Glenmark gets approval from USFDA for asthma drug

GlenmarkPharmaceutical Company, Glenmark said on Wednesday that it has got approval from the US regulator, USFDA for introducing its treatment for asthma.

Its generic theophylline tablets are for treating lung-related diseases. It will be selling these medicines in the American markets.

The approval was given to Glenmark Generics Inc (GGI), which is a subsidiary of Glenmark Generics Ltd. It can now start marketing and distributing this drug, that will be available in 400 mg and 600mg dosages.

In a statement the drug maker said that it has been given 'ANDA (Abbreviated New Drug Application) approval from the United States Food & Drug Administration (USFDA) for theophylline extended-release tablets, the generic version of Purdue Pharmaceutical Products, LP Uniphyl'.

The market for the drug is $8 million for a year and GCI expects to have a successful launch and a have a good market share as it caters the niche market.

Theophylline- based drugs are used for treating obstructions related to airflow and asthma is just one kind of disease.

Post the approval, Glenmark now has 56 generic drugs that have been given approval for marketing and distribution in US. It also has a list of 50 other drugs.