X
Pharma Advancement
  • Home
  • Articles
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    FDA Accepts BLA for Recommended

    FDA Accepts BLA for Recommended Biosimilar to Simponi

    Merck to Acquire Verona

    Merck to Acquire Verona Pharma in $10B Deal Boosts COPD Drug

    Emerging Oral Small Molecule Drugs

    Emerging Oral Small-Molecule Drugs for Ultra-Rare Diseases

    FDA Approves Oral Therapy for Treating Hereditary Angioedema

    FDA Approves Oral Therapy for Treating Hereditary Angioedema

    Avadel Pharmaceuticals Receives

    Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension for the Treatment of Idiopathic Hypersomnia

    Robots and AI in Drug

    Robots and AI in Drug Discovery Are Transforming Medicine

    Stringent Policy around COVID Vaccines Laid by FDA

    Stringent Policy around COVID Vaccines Laid by FDA

    Pharmaceutical-Chemicals Market Booms with Rising API Demand

    Pharmaceutical Chemicals Market Booms with Rising API Demand

    Next in Pharma 2025 Innovations

    Next in Pharma 2025: Innovations Shaping the Future

  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Articles
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    FDA Accepts BLA for Recommended

    FDA Accepts BLA for Recommended Biosimilar to Simponi

    Merck to Acquire Verona

    Merck to Acquire Verona Pharma in $10B Deal Boosts COPD Drug

    Emerging Oral Small Molecule Drugs

    Emerging Oral Small-Molecule Drugs for Ultra-Rare Diseases

    FDA Approves Oral Therapy for Treating Hereditary Angioedema

    FDA Approves Oral Therapy for Treating Hereditary Angioedema

    Avadel Pharmaceuticals Receives

    Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension for the Treatment of Idiopathic Hypersomnia

    Robots and AI in Drug

    Robots and AI in Drug Discovery Are Transforming Medicine

    Stringent Policy around COVID Vaccines Laid by FDA

    Stringent Policy around COVID Vaccines Laid by FDA

    Pharmaceutical-Chemicals Market Booms with Rising API Demand

    Pharmaceutical Chemicals Market Booms with Rising API Demand

    Next in Pharma 2025 Innovations

    Next in Pharma 2025: Innovations Shaping the Future

  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development FDA Approvals

NATCO Pharma Limited receives USFDA tentative approval for Sorafenib Tablets, 200mg

Yuvraj_pawp by Yuvraj_pawp
4th June 2016
in FDA Approvals

Note* - All images used are for editorial and illustrative purposes only and may not originate from the original news provider or associated company.

Natco Pharma Limited announced that its marketing partner, Mylan Inc has received a tentative approval for its Abbreviated New Drug Application (ANDA) for Sorafenib Tablets, 200mg, with the U.S. FDA.

 

This product is the generic version of NEXAVAR®, which is indicated for the treatment of certain types of cancers including unresectable hepatocellular carcinoma and advanced renal cell carcinoma.

 

NATCO and Mylan have filed an ANDA containing a Paragraph IV certification for this product. NATCO manufactures this product at its facility in Kothur, Mahaboobnagar District, Telangana State, India.

 

Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc., sells Sorafenib Tablets, 200mg, under Brand name NEXAVAR®, in the U.S. market. For the 12 months ending Dec. 31, 2015, NEXAVAR® had U.S. sales of approximately $300 million.(SOURCE: Bayer’s Annual Report

Tags: Asia Pacific
Previous Post

Promius Pharma launches Sernivo spray for Plaque psoriasis

Next Post

Alexion Announces Topline Results from Phase 3 REGAIN Study of Eculizumab

Related Posts

FDA Accepts BLA for Recommended
FDA Approvals

FDA Accepts BLA for Recommended Biosimilar to Simponi

22nd July 2025
FDA Approves Oral Therapy for Treating Hereditary Angioedema
FDA Approvals

FDA Approves Oral Therapy for Treating Hereditary Angioedema

15th July 2025
Avadel Pharmaceuticals Receives
Drug Development

Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension for the Treatment of Idiopathic Hypersomnia

9th June 2025
Stringent Policy around COVID Vaccines Laid by FDA
FDA Approvals

Stringent Policy around COVID Vaccines Laid by FDA

29th May 2025
Drug Development

Global Biopharma Market to Hit $566B by 2032

7th March 2025
FDA Approvals

LAI Antipsychotic – Given The Green Light Across The EU

13th April 2024
Next Post

Alexion Announces Topline Results from Phase 3 REGAIN Study of Eculizumab

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Subscribe Us

System

  • Search
  • Sitemap
  • RSS Feed

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack
  • Newsletters Archive

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Articles
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In