First generic Sustiva tablets launched in USA
Netherlands-incorporated Mylan (Nasdaq: MYL) today announced the US launch of efavirenz tablets USP, 600mg.
Mylan says this is the first generic version of Bristol-Myers Squibb's (NYSE: BMY) Sustiva. The product is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) type 1 infection in adults and in pediatric patients at least three months old and weighing at least 3.5kg.
According to the Food and Drug Administration approval letter, Mylan was one of the first applicants to submit a substantially complete Abbreviated New Drug Application (ANDA) for efavirenz tablets USP, 600mg, containing a Paragraph IV certification, and is eligible for 180 days of generic drug exclusivity. The drug had US sales of around $113 million for the 12 months ending December 31, 2017, according to IQVIA data quoted by Mylan.
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