06 febrero 2013

FDA Approves Generic Doxil to Combat Drug Shortage .

It can pay to play with the FDA when it needs help with drug shortages. In a push to ease a months-long shortage of Johnson & Johnson's ($JNJ) cancer drug Doxil, the FDA fast-tracked a generic from Sun Pharma, approving it Monday.

Since February, the FDA had been allowing Sun to import its unapproved version of the Doxil substitute as one way for the agency to address the shortage.

Doxorubicin hydrochloride liposome injection sits on the FDA's drug shortage list, meaning the regulatory agency's Office of Generic Drugs can use a priority review system to bump a generic application for the drug to the front of the line.
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