Active Stocks
Thu Mar 28 2024 15:59:33
  1. Tata Steel share price
  2. 155.90 2.00%
  1. ICICI Bank share price
  2. 1,095.75 1.08%
  1. HDFC Bank share price
  2. 1,448.20 0.52%
  1. ITC share price
  2. 428.55 0.13%
  1. Power Grid Corporation Of India share price
  2. 277.05 2.21%
Business News/ Industry / Manufacturing/  Jubilant Life Sciences gets FDA nod
BackBack

Jubilant Life Sciences gets FDA nod

Jubilant Life Sciences gets nod for generics Mycophenolate Mofetil, an immuno-suppressant, and Rizatriptan, used for treatment of migraine

Jubilant Life Sciences got approvals for Mycophenolate Mofetil in the strengths of 250 mg capsules and 500 mg tablets, and Rizatriptan tablets in the strengths of 5 mg and 10 mg.Premium
Jubilant Life Sciences got approvals for Mycophenolate Mofetil in the strengths of 250 mg capsules and 500 mg tablets, and Rizatriptan tablets in the strengths of 5 mg and 10 mg.

New Delhi: Drug firm Jubilant Life Sciences Ltd has received final approvals from the US health regulator for its generics Mycophenolate Mofetil, an immuno-suppressant, and Rizatriptan, used for treatment of migraine, in the US market.

The company has received final approvals from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Mycophenolate Mofetil capsules and tablets, manufactured by the company’s US arm Jubilant Cadista Pharmaceuticals Inc., and Rizatriptan tablets made at Jubilant Generics Ltd, Jubilant Life Sciences said in a filing to BSE. The approvals are for Mycophenolate Mofetil in the strengths of 250 mg capsules and 500 mg tablets and Rizatriptan tablets in strengths of 5 mg and 10 mg, it added. The company’s Mycophenolate Mofetil is a generic version of Roche’s Cellcept while Rizatriptan tablets are generics of Merck’s Maxalt tablets.

“The current annualized US market size for Mycophenolate Mofetil USP, 250 mg capsules and 500 mg tablets, is $245 million and for Rizatriptan Tablets 5 mg and 10 mg it is $70 million, as per IMS" Jubilant Life Sciences said. As on 30 September 2014, the company had a total of 781 filings for formulations, of which 322 have been approved in various regions globally. This includes 72 ANDAs filed in the US and 46 dossier filings in Europe, it added. Shares of Jubilant Life Sciences on Monday closed 0.21% down at 139.70 per scrip on BSE.

(The promoters of HT Media Ltd, which publishes Hindustan Times and Mint, and Jubilant Life Sciences are closely related. There are no promoter crossholdings.)

Unlock a world of Benefits! From insightful newsletters to real-time stock tracking, breaking news and a personalized newsfeed – it's all here, just a click away! Login Now!

Catch all the Industry News, Banking News and Updates on Live Mint. Download The Mint News App to get Daily Market Updates.
More Less
Published: 05 Jan 2015, 11:43 PM IST
Next Story footLogo
Recommended For You
Manufacturing Stocks
₹557.550.52%
ITC
₹4280.13%
₹2,987.85-0.37%
₹152.852%
Switch to the Mint app for fast and personalized news - Get App