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Tag: fda approval
FDA Pulls Approval for Dog Antifreeze Antidote
2015-04-14 22:44:09| Food - Topix.net
The U.S. Food and Drug Administration withdrew approval for Antizol-Vet, an antidote for antifreeze poisoning in dogs available through veterinarians, at the request of the drug's sponsor, Paladin Labs Inc. Paladin Labs requested that the FDA withdraw the approval because the company has not manufactured or marketed the drug since Oct. 1, 2014. The most recent lot marketed in the U.S. is lot #1319-12A with an expiration date of August 2017.
FDA Pulls Approval for Dog Antifreeze Antidote
2015-04-14 21:51:35| Agriculture - Topix.net
The U.S. Food and Drug Administration withdrew approval for Antizol-Vet, an antidote for antifreeze poisoning in dogs available through veterinarians, at the request of the drug's sponsor, Paladin Labs Inc. Paladin Labs requested that the FDA withdraw the approval because the company has not manufactured or marketed the drug since Oct. 1, 2014. The most recent lot marketed in the U.S. is lot #1319-12A with an expiration date of August 2017.
Therapure Innovations Receives FDA Approval To Proceed With A Phase 1 Clinical Trial Of The Targeted Liver Cancer Therapeutic TBI 302
2015-04-01 08:23:10| drugdiscoveryonline Home Page
Therapure Innovations, a division of Therapure Biopharma Inc., recently announces that the U.S. Food and Drug Administration (FDA) has given the company approval to proceed with a Phase 1 clinical trial of TBI 302, a targeted therapeutic for the treatment of liver cancer
Tags: trial
phase
approval
cancer
BRILINTA Receives US FDA Approval For New Administration Option
2015-04-01 08:02:52| drugdiscoveryonline Home Page
AstraZeneca recently announced that the US Food and Drug Administration (FDA) has approved a new administration option for acute coronary syndrome (ACS) patients who are unable to swallow BRILINTA 90 mg tablets whole
Tags: option
administration
approval
receives
BIO addresses FDA approval of biosimilar product.
2015-03-10 13:31:09| Industrial Newsroom - All News for Today
BIO issued statement regarding approval by FDA of the first biosimilar product under the pathway created by the Biologics Price Competition and Innovation Act. According to Jim Greenwood, BIO President and CEO, for more than a decade, BIO has called for open, transparent, and science-based dialogue regarding biosimilars. It is unfortunate that the lack of publicly available naming guidance resulted in FDA's assignment of a "placeholder" name for approved biosimilar.
Tags: product
approval
addresses
bio
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