Mylan Inc.’s (MYL) generic unit received encouraging news when the U.S. Food and Drug Administration (FDA) approved the supplemental Abbreviated New Drug Application (sANDA) for its generic version of GlaxoSmithKline’s (GSK) Wellbutrin XL (Bupropion Hydrochloride Extended-release) 300 mg tablets- an antidepressant.
The sANDA, filed in Apr 2013, contained results of the bioequivalence (BE) study requested by the U.S. regulatory body. Mylan filed the sANDA following the directive issued by the FDA in Dec 2012 to all generic companies marketing a version of Bupropion Hydrochloride Extended-release 300 mg tablets. The FDA asked the companies to conduct a fasting BE study comparing their version of the product to its branded version. Mylan’s BE study results impressed the FDA which resulted in the approval of the sANDA.
Mylan, one of the largest players in the global generics market, has a presence in more than 140 countries. As of Aug 22, 2013, the company had 179 ANDAs pending FDA approval, representing $84 billion in annual sales. These include 42 first-to-file opportunities, representing $23.8 billion in annual sales. The data released by IMS Health is for the twelve-month period ending Dec. 31, 2012.
Mylan’s generic unit has seen quite a few launches over the past few months. One of the important recent launches includes the company's generic version of Pfizer Inc.’s (PFE) erectile dysfunction drug Viagra.
Mylan carries a Zacks Rank #3 (Hold). Actavis, Inc. (ACT) appears to be well placed in the generic space with a Zacks Rank #2 (Buy).
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