The US Food and Drug Administration (FDA) recently accepted
) new drug application for its oral contraceptive candidate. The
company is looking to get its progestin-only transdermal
contraceptive patch (norethindrone transdermal delivery system)
approved for the prevention of pregnancy.
With the FDA granting standard review to the NDA, a response
should be out by Dec 27, 2013. The NDA was submitted on Feb 26,
2013 and includes data from a 12-month, multicenter, open-label
The once-weekly dosing regimen of the patch could help improve
compliance and convenience in progestin-only contraceptive
Actavis is working on strengthening its women's health
business. Earlier this year, the company acquired Belgium-based
Uteron Pharma. With this acquisition, Actavis gained a portfolio
of two late-stage, one mid-stage and several early-stage pipeline
Uteron's two-late stage candidates are Levosert, an
intrauterine device (IUD) for long-term contraception and the
treatment of heavy bleeding and Diafert, a non-invasive
immunoassay kit for the determination of the quality of oocyte
(egg) during in-vitro fertilization (IVF).
While Levosert is currently under review in several EU
countries, Diafert could obtain EU approval later this year. As
far as the US is concerned, Levoset is currently in phase III
development. Diafert is slated to enter into phase III
development this year in the US.
Estelle, Uteron's mid-stage pipeline candidate, is a
contraceptive that could be launched in 2018.
Actavis currently carries a Zacks Rank #3 (Hold). With fewer
major patent expiries slated to occur in the next few years, we
are encouraged by Actavis' focus on building its branded and
In the pharma/biopharma space, companies that currently look
Salix Pharmaceuticals, Ltd.
). All three are Zacks Rank #1 (Strong Buy) stocks.
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