U.S. FDA approves first generic drug for asthma and COPD treatment
Category: #health  By Mateen Dalal  Date: 2019-01-31
  • share
  • Twitter
  • Facebook
  • LinkedIn

U.S. FDA approves first generic drug for asthma and COPD treatment

The generic drug will mean low cost but high-quality drug access to people suffering from chronic respiratory and lung diseases.

The U.S. Food and Drug Administration recently announced that it has approved the first generic version of Advair Diskus for asthma treatment in patients aged four years and above. Approval has been granted for 500 mcg/50 mcg, 250 mcg/50 mcg and 100 mcg/50 mcg doses of the generic drug, which is indicated for twice daily treatment of patients suffering from chronic obstructive pulmonary disease which include emphysema and bronchitis besides being approved for asthma.

The newly approved generic drug is reported to contain long-acting beta(2)-adrenergic agonist (LABA) and corticosteroid which help in reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) and treatment of airflow obstruction. For the record, this is a complex drug-device combination medical product and no generic medical product of the same kind has won an FDA approval before this.

Janet Woodcock, MD and director of Center for Drug Evaluation and Research, FDA, has been reported by a press release to say that the approval of the generic drug product for the most frequently prescribed asthma and COPD inhalers in the country, demonstrates FDA’s commitment towards advancing access to high quality yet low-cost generic alternatives. She added that people with COPD and asthma understand and experience the critical importance of being able to afford the treatment to feel healthy and the recent approval is yet another step towards benefitting those who rely on this drug besides increasing market competition.

For the record, 26 million people in the U.S., which includes children as well, suffer from asthma while an additional 16 million people have to fight COPD. Availability of generic medicines for these disorders are a basic benefit that the citizens will be able to access through the recent approval.

According to sources, the FDA approves of generic drugs once it is satisfied that the generic drug is as effective and as safe as the brand name drug. For this approval the generic drug has to undergo rigorous approval standards. The generic drug also has to maintain the same packaging and manufacturing standards as the branded drug.

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal    

Mateen Dalal

A qualified electronics and telecommunication engineer, Mateen Dalal embarked on his professional journey working as a quality and test engineer. Harnessing his passion for content creation however, Mateen pens down industry-rich articles for ReportsGO.com and a few o...

Read More

More News By Mateen Dalal

Apple intends to inaugurate its new $1Bn campus in Texas by 2022
Apple intends to inaugurate its new $1Bn campus in Texas by 2022
By Mateen Dalal

The U.S – China trade war has been terrorizing the global economy since the dawn of 2018. It has affected the overall financial market and global supply chains. This ongoing trade war has had a negative impacted U.S. tech giant Apple’s sh...

Salesforce to use Amazon’s cloud to enhance call center services
Salesforce to use Amazon’s cloud to enhance call center services
By Mateen Dalal

Salesforce will use Amazon Web Services’ technology to turn customer’s spoken words into text.   The partnership will bring Amazon and Salesforce into more direct competition with call center technology service providers. Sales...

FDA warns Dollar Tree regarding the sale of imported adulterated drugs
FDA warns Dollar Tree regarding the sale of imported adulterated drugs
By Mateen Dalal

FDA’s new warning letter is asking Dollar Tree to ensure the company does not import adulterated medicines   Manufacturers mentioned in the letter include Hangzhou Zhongbo and Shanghai Weierya Daily Chemicals Reports confirm that the...