Division of Novartis AG
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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.
More meeting requests are being denied because the sponsor's pre-meeting package was incomplete, the agency said.
As ranitidine suspensions and recalls mount worldwide, US agency says heat of pharmacy lab's test made nitrosamine levels appear high.
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.
- Generic Drugs
- Therapeutic Areas
- North America
- Parent & Subsidiaries
- Novartis AG
- Senior Management
Greg Nulty, VP, Head, Finance & CFO
Patrick Genestin, VP, Bus. Dev. & Licensing
Carlos Sattler, MD, VP, Clin. Dev. & Medical Affairs
Scott Smith, VP, Commercial Operations, US
Anthony Maffia, III, VP, Regulatory Affairs
Carol Lynch, Pres.
- Contact Info
Phone: (609) 627-8500
100 College Rd. West
Princeton, NJ 08540
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