The FDA has now signed off on Janssen's process of manufacturing bulk Doxil at an Ohio facility. It is part of an "alternative manufacturing process" in which the company hands off fill and finish of the drug to another manufacturer.
Johnson & Johnson's Janssen, which has struggled to maintain ready supplies of its ovarian cancer treatment Doxil, has released a new lot of the popular drug. The injectable cancer med was produced through an "alternative manufacturing approach" in which the now-closed Ben Venue plant in Ohio made the bulk product and another manufacturer finished it off.
In defending the largest state-level decision ever won against Johnson & Johnson for its Risperdal marketing, the state of Arkansas said the New-Jersey based company didn't properly communicate the antipsychotic's risks and marketed it for off-label use. In its appeal, J&J said it didn't commit fraud or harm the state's Medicaid program. But Arkansas' Supreme Court had something entirely different to say when it overturned the $1.2 billion judgment Thursday.
Looks like the FDA has taken an advisory committee's Xarelto concerns to heart. Following up on an overwhelming "no" vote from last month, the agency Friday issued Johnson & Johnson's Janssen unit complete response letters regarding use of the anticoagulant in ACS patients.
Janssen and Ben Venue officials have assured a federal court that any operations Janssen initiates at Ben Venue's now-closed Ohio facility will comply with provisions of a consent decree that Ben Venue signed last year. The move came the same day that production officially ceased at the plant, which was the sole supplier of Doxil.
Janssen Pharmaceuticals, which has struggled to maintain supplies of its cancer drug Doxil since supplier Ben Venue Laboratories ran into FDA issues, may have landed on a way to help keep supplies available. The Johnson & Johnson unit has an agreement to lease part of Ben Venue's Bedford, OH, plant and take on manufacturing itself.
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A Philadelphia jury didn't buy Johnson & Johnson's argument that it had properly warned doctors and patients about the birth-defect risks associated with its seizure drug Topamax. The panel ordered J&J's Janssen unit to pay $11 million to Haley Powell, whose son was born with a cleft palate.
The saga of the shortage of ovarian cancer drug Doxil has hit a new turning point, and not for the better. Johnson & Johnson has indicated it will have no supplies of the popular drug until at least the end of next year because its sole supplier is permanently closing the plant that makes it and it will be unable to get new suppliers approved for another 12 months or more.
Johnson & Johnson, which has been battling a host of problems tied to its consumer healthcare operations, is back in the baby powder business in Mumbai, India. A plant that was ordered closed by authorities there three months ago has been allowed to resume production.