Sanwa Kagaku Kenkyusho Co., Ltd.
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As the global generics industry had predicted, the unexpected growth seen in the first quarter of 2020 due to forward buying caused by COVID-19 levelled off in the second quarter. However, a few companies managed to report a “mixed” second quarter or a positive first half for 2020, even after experiencing challenges, such as operational interruptions, posed by the pandemic.
Despite the door being opened for generic competition to Restasis more than a year, no FDA approvals for ANDAs referencing the eye-disease drug have been forthcoming. However, that could change before the year is out.
Legal experts say any firm distributing products associated with COVID-19 should expect to receive the highest level of scrutiny as the US FDA resumes inspections and uses its enforcement muscle to prohibit companies from making adulterated products, such as hand sanitizers, or making fraudulent claims.
Amneal is adding to its portfolio of complex products with FDA approval for a generic version of Lidoderm.
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