Medindia

X

Chewable Tablets For Asthma and Allergies Get FDA Approval

by Julia Samuel on  March 3, 2015 at 6:05 PM Drug News   - G J E 4
Montelukast Sodium chewable tablets used in the treatment of asthma and to relieve symptoms of seasonal allergies developed by Jubilant Life Sciences received final approval for the generic from the US health regulator.
Chewable Tablets For Asthma and Allergies Get FDA Approval
Chewable Tablets For Asthma and Allergies Get FDA Approval
Advertisement

Jubilant Life Sciences said in a statement, "The company has received abbreviated new drug application (ANDA) final approval from the US Food and Drug Administration (USFDA) for Montelukast Sodium chewable tablets of 4 mg and 5 mg."

Advertisement
The company had a total of 781 filings for formulations of which 333 have been approved in various regions globally and includes 72 ANDAs filed in the US, of which 35 have been approved and 46 dossier filings in Europe. So far, it has received 10 ANDA approvals during FY2015.

"The total market size for Montelukast tablets as per IMS is USD 83 million per annum," Jubilant Life Sciences said. The tablets are generic version of Merck's Singulair chewable tablets used for the treatment of asthma and to relieve symptoms of seasonal allergies, it added.

Source: Medindia
Advertisement

Post your Comments

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
User Avatar
* Your comment can be maximum of 2500 characters
Notify me when reply is posted I agree to the terms and conditions

You May Also Like

Advertisement
View All