Indian generics firm Ranbaxy voluntarily withdrew one batch of its acne drug isotretinoin from US shelves late last week after FDA analysis revealed out of spec dissolution test results.
Ranbaxy said that the recall, which is limited to 1303 cartons of 100 isotretinoin capsules, is a precautionary measure and added that the product “is not likely to cause adverse health consequences.”
In 2008 the drug was one of 30 subject to an import ban by the Food and Drug Administration (FDA) for good manufacturing practice (GMP) violations, although Ranbaxy was permitted to sell remaining stocks as it was deemed not to be unsafe.
Prior to the FDA ruling isotretinoin was one of Ranbaxy’s top five sellers in the US, generating around $50m (€36m) in annual revenue, equivalent to one third of the country’s total market.
Since the ban however, the product’s market share has fallen and, according to comments made by HDFC Securities’ VP of institutional research Ranjit Kapadia in an Economic Times interview, Ranbaxy will only lose $1m as a result of the recall.
While the withdrawal clearly benefits competitors like Barr, Genpharm and Mylan, of more significance is the fact that isotretinoin is the second drug, after nitrofurantoin, which Ranbaxy has had to pull after out of spec test results this year.
Whether the FDA, which is currently reviewing Ranbaxy’s proposed remediation to the import ban, will view the latest recall as a prompt response to a limited manufacturing issue or as indicative of wider problems remains to be seen.
Either way, Ranbaxy and Japanese owner Daiichi Sankyo, which expect a final FDA decision on the import ban to be announced in the “near future,” will hope that the latest recall is not detrimental to efforts to rebuild US sales.
Roche pulls originator drug
Ranbaxy’s move also follows hot on the heels of Roche’s decision to discontinue Accutane, the original branded version of isotretinoin, after the US courts awarded $33m in damages to patients who claimed that the drug had caused bowel disease.
Roche said that although it “stands behind the safety of Accutane and [its] rigorous risk management programme,” the impact of generic competition, a portfolio re-evaluation and the cost of injury lawsuits had prompted its decision.
The Swiss firm added that it is committed to working with the FDA and generic manufacturers to ensure that isotretinoin supplies in the US are maintained at an appropriate level.