) 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
) 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
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
) erectile dysfunction drug Viagra.
Mylan carries a Zacks Rank #3 (Hold).
) appears to be well placed in the generic space with a Zacks
Rank #2 (Buy).
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