In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Sandoz Inc.

Division of Novartis AG
www.us.sandoz.com

Latest From Sandoz Inc.

Biosimilars: US FDA Ends FY 2019 With Record Number Of Approvals, One Complete Response Letter

Agency approved 11 biosimilars from six sponsors with only one publicly disclosed complete response letter (Tanvex’s filgrastim). Pink Sheet infographic shows 351(k) application submission, approval and CRL rates over the life of the user fee program.

 

Biosimilars Review Pathway

US FDA Still Fighting Problems With Pre-ANDA Meeting Requests

More meeting requests are being denied because the sponsor's pre-meeting package was incomplete, the agency said.

Drug Review Generic Drugs

US FDA Questions Valisure’s Zantac Carcinogenicity Findings

As ranitidine suspensions and recalls mount worldwide, US agency says heat of pharmacy lab's test made nitrosamine levels appear high.

Manufacturing Quality

Novartis Takes Piqray To India With Affordability Pledge

Novartis’s breast cancer therapy Piqray is endorsed by an expert panel for marketing in India and the Swiss company has emphasized its commitment to value-based pricing for the product.

Policy & Regulation India
See All

Company Information

Advertisement
Advertisement
UsernamePublicRestriction

Register