The US Food and Drug Administration (FDA) has granted approval to Mylan Inc's supplemental Abbreviated New Drug Application (sANDA) providing bioequivalence study results requested by FDA for Bupropion Hydrochloride (HCl) Extended-release (ER) tablets USP (XL), 300 mg. Bupropion HCl ER tablets USP (XL) are the generic version of Wellbutrin XL and are indicated for the treatment of major depressive disorder (MDD).
Mylan launched its Bupropion HCl ER Tablets USP (XL), 150 mg and 300 mg, to the US market in September 2010.
In a correspondence issued December 2012, FDA requested all generic drug companies marketing a version of Bupropion HCl ER Tablets, 300 mg, to conduct a fasting bioequivalence (BE) study comparing their Bupropion HCl ER tablets, 300 mg, to GSK's Wellbutrin XL (Bupropion Hydrochloride Extended-release) tablets, 300 mg. In April 2013, Mylan submitted to FDA a sANDA containing the requested study, which demonstrated bioequivalence of Mylan's Bupropion HCl ER Tablets USP (XL), 300 mg, to Wellbutrin XL tablets, 300 mg.
For the 12 months ending June 30, 2013, Bupropion Hydrochloride extended-release tablets, 150 mg and 300 mg, had US sales of approximately $503.3 million, according to IMS Health.
Currently, Mylan has 179 ANDAs pending FDA approval representing $84 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $23.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2012, according to IMS Health.