Hospira on track to return propofol to market
pharmafile | November 13, 2012 | News story | Manufacturing and Production |Â Â Ball, Hospira, TevaÂ
Shortages of the short-acting anaesthetic propofol in the US could be helped by the return to market of a generic version of the drug made by Hospira early next year.
Hospira was one of the major suppliers of propofol in the US but has been struggling to overcome quality problems at three of its manufacturing plants, with the last couple of years punctuated by a string of product recalls ordered as a result of contamination of vials with particulate matter and other defects.
As recently as August, the firm recalled three lots of propofol injectable emulsion due to visible particles embedded in the glass vials which may have become dislodged into the drug solution.
Hospira’s problems exacerbated an already-precarious propofol supply, which had been hit hard by the withdrawal of Israeli generics manufacturer Teva from the market in May 2010. Teva closed down its US facility making the anaesthetic after a patient contracted hepatitis C from a 50ml vial of the product.
The other major supplier – Fresenius Kabi USA – has been releasing propofol to authorised wholesalers as it gets manufactured, but cannot keep up with increasing demand for the product, according to the American Society of Health-System Pharmacists (ASHP).
On Hospira’s third-quarter results call, chief executive Michael Ball confirmed that the company has started production runs for propofol at its facility in Clayton, Colorado, and is now ramping up supply with a view to re-launching the product in the coming months.
“We want to have an adequate supply of product prior to our re-entry into the market, which we ultimately expect to be late this year or early next year,” said Ball. He noted that Hospira continues to carry out remediation activities at its other under-performing facilities.
The Austin plant was inspected in the third quarter and received a ‘483 notice from the FDA inspectors with 19 observations that needed attention. Ball said responses to these have been filed with the FDA.
Remediation on the Rocky Mount facility is continuing, with the next milestone an FDA inspection in the coming months. However, recent inspections of Hospira’s IKKT anti-infective facility in India and McPherson plant in the US did prompt ‘483 notices which the company is now trying to address.
Operation of the IKKT facility was temporarily suspended recently so Hospira could “address certain observations related to aseptic practices and … put our operators through an extensive retraining and certification process”. Production at the plant has since resumed, said Ball.
Phil Taylor
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