Tuesday, Jun 28, 2022
English News
  • Hyderabad
  • Telangana
  • Andhra Pradesh
  • India
  • World
  • Entertainment
  • Science and Tech
  • Sport
  • Business
  • ...
    • NRI
    • View Point
    • cartoon
    • Columns
    • Reviews
    • Education Today
    • Property
    • Videos
    • Lifestyle
E-Paper
  • NRI
  • View Point
  • cartoon
  • Columns
  • Reviews
  • Education Today
  • Property
  • Videos
  • Lifestyle
Home | Business | Zydus Gets Final Usfda Approval To Market Roflumilast Tablets
Ads

Zydus gets final USFDA approval to market Roflumilast tablets

By PTI
Published: Published Date - 01:34 PM, Mon - 14 February 22
Source: IANS

New Delhi: Cadlia Healthcare Ltd on Monday said group firm Zydus Pharmaceuticals (USA) Inc has received final approval from the US health regulator to market its generic version of Roflumilast tablets in the strength of 500 mcg indicated to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations.

Zydus, being one of the first applicants for Roflumilast Tablets, 500 mcg, is eligible for 180 days of shared generic drug exclusivity, Cadlia Healthcare said in a regulatory filing.
The US Food and Drug Administration (USFDA) has also given a tentative approval for Roflumilast tablets, 250 mcg, the company added.

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.

Roflumilast tablets are indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations, it added.

The group now has 327 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.


Now you can get handpicked stories from Telangana Today on Telegram everyday. Click the link to subscribe.

Click to follow Telangana Today Facebook page and Twitter .


  • Follow Us :
  • Tags
  • Ahmedabad
  • Cadlia Healthcare
  • pulmonary disease
  • Roflumilast tablets

Related News

  • Three prominent persons join AAP in Gujarat

  • SC grants paternal grandparents custody of COVID orphaned child from maternal aunt

  • Want to win the World Cup for India no matter what happens: Hardik Pandya

  • IPL 2022: Orange cap winner Jos Buttler ‘disappointed’ as RR lose to GT

  • IPL 2022: Ahmedabad to host final and Qualifier 2

  • UK PM Boris Johnson arrives in India for two-day visit

Latest News

  • Hooda’s maiden century helps India beat Ireland by 4 runs to pocket series 2-0

    4 hours ago
  • Opinion: Time to rehabilitate Gutti Koyas

    5 hours ago
  • Wimbledon 2022: Swiatek continues dream run, wins 36th match in a row

    5 hours ago
  • Editorial: Fair share to women

    5 hours ago
  • Web 3.0, Metaverse decentralising content, say experts at T-Hub Innovation Summit

    4 hours ago
  • Fuel outlets face diesel shortage in Hyderabad

    5 hours ago
  • Prathul, Aadya bag top honours in TS U-7 Chess National Selection Tournament

    5 hours ago
  • Utilise young talent from rural areas: KCR to officials

    5 hours ago

company

  • Home
  • About Us
  • Contact Us

business

  • Subscribe

telangana today

  • Telangana
  • Hyderabad
  • Latest News
  • Entertainment
  • World
  • Andhra Pradesh
  • Science & Tech
  • Sport

follow us

© Copyrights 2022 TELANGANA PUBLICATIONS PVT. LTD. All rights reserved. Powered by Veegam