Unichem Labs gets USFDA nod for migraine tablets

Image
Press Trust of India New Delhi
Last Updated : Mar 08 2017 | 4:07 PM IST
Drug firm Unichem Laboratories said today it has received approval from the US health regulator for its Rizatriptan Benzoate tablets used for the treatment of migraine.
The company "has received abbreviated new drug application (ANDA) approval from the United States Food and Drug Administration (USFDA) for Rizatriptan Benzoate ODT, 5mg & 10mg and Rizatriptan Benzoate Tablets USP, 5mg & 10mg...," Unichem Laboratories said in a filing to BSE.
The tablets are generic versions of Merck & Company Inc's Maxalt - MLT tablets 5mg & 10mg and Maxalt tablets 5mg, 10mg, it added.
The product will be commercialised from the company's Goa plant. Active Pharmaceutical Ingredient will also be made in-house at Roha API Plant, Unichem Laboratories said.
The tablets are indicated for acute treatment of migraine in adults and in pediatric patients of 6 to 17 years of age.
Shares of Unichem Laboratories were trading at Rs 264.10 in the afternoon trade on BSE, up 0.40 per cent from its previous close.

Disclaimer: No Business Standard Journalist was involved in creation of this content

*Subscribe to Business Standard digital and get complimentary access to The New York Times

Smart Quarterly

₹900

3 Months

₹300/Month

SAVE 25%

Smart Essential

₹2,700

1 Year

₹225/Month

SAVE 46%
*Complimentary New York Times access for the 2nd year will be given after 12 months

Super Saver

₹3,900

2 Years

₹162/Month

Subscribe

Renews automatically, cancel anytime

Here’s what’s included in our digital subscription plans

Exclusive premium stories online

  • Over 30 premium stories daily, handpicked by our editors

Complimentary Access to The New York Times

  • News, Games, Cooking, Audio, Wirecutter & The Athletic

Business Standard Epaper

  • Digital replica of our daily newspaper — with options to read, save, and share

Curated Newsletters

  • Insights on markets, finance, politics, tech, and more delivered to your inbox

Market Analysis & Investment Insights

  • In-depth market analysis & insights with access to The Smart Investor

Archives

  • Repository of articles and publications dating back to 1997

Ad-free Reading

  • Uninterrupted reading experience with no advertisements

Seamless Access Across All Devices

  • Access Business Standard across devices — mobile, tablet, or PC, via web or app

More From This Section

First Published: Mar 08 2017 | 4:07 PM IST

Next Story