The US drug
regulator said it will import generic version of the cancer drug Lipidox from Sun Pharma to meet a supply shortage. A generic drug has to get clearance from the US Food and Drug Administration
to be sold in the US market, but in this rare case, the drug regulator
agreed to import because of an acute shortage of the approved drug.
Analysts said the decision opens up opportunities for Indian drug generic makers. There are close to 287 essential drugs that are in short supply in the US.
A statement released by USFDA late Tuesday said, "Under FDA's exercise of enforcement discretion the chemotherapeutic drug Lipodox will be imported as an alternative to Doxil."
Doxil, a patented anti-cancer drug, is manufactured by Johnson & Johnson.
FDA's exercise of enforcement discretion for Lipodox is a temporary, limited arrangement specific to Sun Pharma Global FZE and its authorised distributor, Caraco Pharmaceutical, the FDA said.
Sun Pharma did not specify for how long will it supply the medicines, but analysts said the company will get a one-time payment for the transaction.
Analysts said the decision opens up opportunities for Indian drug generic makers. There are close to 287 essential drugs that are in short supply in the US.
A statement released by USFDA late Tuesday said, "Under FDA's exercise of enforcement discretion the chemotherapeutic drug Lipodox will be imported as an alternative to Doxil."
Doxil, a patented anti-cancer drug, is manufactured by Johnson & Johnson.
FDA's exercise of enforcement discretion for Lipodox is a temporary, limited arrangement specific to Sun Pharma Global FZE and its authorised distributor, Caraco Pharmaceutical, the FDA said.
Sun Pharma did not specify for how long will it supply the medicines, but analysts said the company will get a one-time payment for the transaction.
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