FDA fast-tracks plant for injectable on shortage list

Cook Pharmica not required to go through preapproval inspection
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The FDA has been flexible in finding new sources when crucial drugs are in short supply. In the most recent example, Cook Pharmica says the agency approved its manufacturing facility without doing a preapproval inspection so that it could begin producing a drug that is on the FDA shortage list. The company did not say which drug it was or who it is manufacturing it for, but indicated it was a sterile injectable product. The FDA has bent a number of rules to try to increase supplies of some critical drugs. In February the agency approved a generic version of Johnson & Johnson's ($JNJ) cancer drug Doxil from India's Sun Pharma that it had put through a fast-track approval process. The agency had been allowing Sun to import an unapproved version to help ease a months-long shortage of the drug that escalated after manufacturing issues arose at the contract manufacturing facility where it was made. Release | More

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