J&J sees OTC recovery in Q1
pharmafile | April 23, 2013 | News story | Manufacturing and Production |Â Â J&J, JJ, manufacturing issues, recallÂ
Johnson & Johnson is moving steadily closer to a sustained recovery in its McNeil Consumer Healthcare division as the manufacturing issues that have plagued the firm start to be resolved.
The company reported a rebound in the over-the-counter (OTC) medicines business in the first quarter of the year, largely thanks to the re-launch of products that had seen their production restricted or suspended because of quality failures.
Three facilities in J&J’s manufacturing network are operating under an FDA consent decree, which was implemented in 2011 after the regulator uncovered numerous Good Manufacturing Practice (GMP) violations which had already led to the recall of millions of OTC products.
J&J’s quarterly results statement indicates that US consumer health sales were 14% higher in the first quarter of the year compared to the same period of 2012, with growth driven by a return to market of key products in J&J’s Tylenol and Motrin ranges, amongst others. On a global basis the division’s sales rose 2% to $3.7 billion.
Chief financial officer Dominic Caruso said on a conference call that the company now expects to have 75% of the affected brands back on the market by the end of the year. Children’s Tylenol, antihistamine product Benadryl tablets and Pepcid Complete for heartburn resumed sales during the first quarter.
Of the plants currently under the consent decree, Fort Washington in Philadelphia remains under a total production ban while Lancaster in the US and Las Piedras in Puerto Rico are operating at reduced capacity under strict regulatory scrutiny. Fort Washington is scheduled for re-inspection by the FDA later this year.
Doxil recovery
Meanwhile, there was also positive news on supplies of anticancer drug Doxil/Caelyx (liposomal doxorubicin) a product which has been in short supply for some time owing to manufacturing issues at contract manufacturer Ben Venue Laboratories.
Sales of the drug picked up in the first quarter thanks to the release of batches of the drug made via an alternative manufacturing route in the US, under the regulatory discretion of the FDA, while J&J transitions production to alternative contractors.
Phil Taylor
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