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Pharmacia & Upjohn Inc.

Division of Pfizer Inc.

Latest From Pharmacia & Upjohn Inc.

US FDA Seeks Withdrawal Of Injectable Bacitracin Despite Extensive Off-Label Use

Injectable bacitracin, often used as a surgical irrigant, carries serious risks of nephrotoxicity and anaphylaxis; product is no longer prescribed for its lone approved indication in pediatric pneumonia. FDA’s decision aligns with advisory committee recommendations in 1984 and 2019.

Drug Safety Generic Drugs

Widespread Off-Label Use Could Ensure Injectable Bacitracin's Future

US FDA advisory committee will weigh fate of the injectable antibiotic, which can cause renal failure and is only approved for treatment of pediatric pneumonia. However, its real-world use is almost entirely in the surgical setting for irrigation and prophylaxis. Xellia, one of five companies that markets the generic drug, said the risk/benefit profile for on-label use remains positive and evidence on off-label use warrants further exploration.

Advisory Committees Drug Review

Third Time’s A Charm? Endo’s Injectable Testosterone Finally Ready For Advisory Cmte.

FDA says reports of oil embolism and anaphylactic reations with other testosterone injectables also will be part of the discussion during an April 18 meeting of the Reproductive Health Drugs and Drug Safety and Risk Management advisory committees to review Aveed (testosterone undecanoate).

BioPharmaceutical North America

TissueInformatics Inc.

In 1997, reconstructive surgeon Peter Johnson, MD, the founder and president of the Pittsburgh Tissue Engineering Initiative, saw an opportunity in TissueInformatics Inc. to support the tissue engineering industry with informatics tools that enabled the analysis and digital cataloguing of tissue images and data. But it appears that the usefulness of TissueInformatics' platform extends beyond tissue engineering--the company has come along at just the right time to also serve a growing need for digital tissue analysis tools by biorepositories as well as by pharmaceutical companies using tissue samples to validate genomics discovery efforts.

BioPharmaceutical Platform Technologies
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