Johnson & Johnson (JNJ:US) said it’s exploring ways to resume making the cancer medicine Doxil by September after a production shutdown at a supplier last year contributed to a shortage.
Boehringer Ingelheim GmbH (BING)’s Ben Venue Laboratories factory in Ohio stopped production in November after regulators questioned the product quality. Ben Venue said it may resume operations by the end of 2012. J&J plans to transfer the manufacturing to another supplier, said Lisa Vaga, a spokeswoman for the New Brunswick, New Jersey-based company.
J&J, the world’s second-largest seller of health-care products after Pfizer Inc., may be able to boost its supplies of the drug sooner by having Ben Venue formulate the medication, then transfer it to another company for the filling and packaging of the product, Vaga said in a telephone interview.
“We anticipate health authority approval would be in the September time frame, with limited amount of Doxil available shortly thereafter,” she said. “This is a method for us to try to get Doxil back before the late 2012 time frame when the whole facility would be back up and running.”
The company has been parceling out the remaining supply of the drug to patients under the Doxil C.A.R.E.S. Physician Access Program. J&J sent a letter to doctors last week asking them to re-enroll patients and certify that they are benefiting from the drug. New patients aren’t being accepted into the program, the company said in the letter on its website.
The Food and Drug Administration gave Caraco Pharmaceutical Laboratories Ltd. (CPD:US) permission to import an unapproved drug from India with the same active ingredient as Doxil in February to ease pent-up demand for the medication, used to treat ovarian cancer and multiple myeloma. The agency allows temporary importation of unapproved drugs in rare cases when there is a shortage of medications critical to patients.
Caraco, a generic-drug maker based in Detroit, will temporarily import the drug Lipodox from its Mumbai-based parent, Sun Pharmaceutical Industries Ltd. (SUNP)
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