Mylan cleared to sell generic Wellbutrin XL in USA

There was good news last week for US specialty and generics company Mylan (Nasdaq: MYL), when the US Food and Drug Administration approved the supplemental Abbreviated New Drug Application (sANDA) for its generic version of UK pharma giant GlaxoSmithKline’s (LSE: GSK) antidepressant Wellbutrin XL (bupropion hydrochloride extended-release) 300mg tablets.

For the 12 months ending June 30, 2013, bupropion hydrochloride extended-release tablets, 150mg and 300mg, had US sales of about $503.3 million, according to IMS Health.

The sANDA, filed in Apr 2013, contained results of the bioequivalence study requested by the US regulatory body, commented analysts at Zacks Equity Research. Mylan filed the sANDA following the directive issued by the FDA in December 2012 to all generic companies marketing a version of bupropion hydrochloride extended-release 300mg tablets.