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Sun Pharma In The News

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US FDA to Import Sun's Cancer Generic Lipodox

Shares of Sun Pharma, India's third-largest drug mak­er, rose 4% on Wednesday after the US drug regulator said it will import the generic ver­sion of the cancer drug Lipodox from Sun Pharma to meet a supply shortage.

A generic drug has to get clearance from the US Food and Drug Administration (FDA) 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 the 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. The drug has been in short supply in the US since June last year and the USFDA was under pressure from health activists and doctors to find its generic replace­ment. "A drug shortage can be a frightening prospect for patients and US presi­dent Barack Obama has made it clear that preventing these shortages from happening is a top priority of his administration," said FDA commissioner Margaret A Hamburg. On Wednesday, Sun Pharma shares closed at Rs 549 on BSE, up 1 % from its previous close. Sun Pharma did not specify for how long it will supply the medicines, but analysts said the company will get a one-time payment for the transaction.