) recently gained pediatric exclusivity from the US Food and Drug
Administration (FDA) for its injectable sedation drug, Precedex
(dexmedetomidine HCl). The FDA's decision resulted in a six-month
extension of the period, during which Precedex's generic may not
be cleared following its patent expiry.
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Hospira stated in its press release that the FDA's decision to
grant pediatric exclusivity to Precedex does not imply that the
sedative is approved to treat pediatrics. Precedex continues to
be approved for treating adults. Hospira's pediatric studies on
the drug are currently under FDA review.
Hospira received further good news from the FDA regarding
Precedex when the US regulatory body cleared a premix version of
the drug. The approval of the premix version will provide doctors
with a ready-to-use drug that boasts multiple benefits for
Although impressed by the FDA's decisions on Precedex, we note
that Hospira on the whole is passing through a rough patch due to
the ongoing manufacturing challenges at its Rocky Mountain
facility as well as issues with the Symbiq/Plum pumps. The
ongoing manufacturing issues at its Rocky Mountain facility have
hurt the company's earnings over the last few quarters. The
issue, until resolved, will remain a major overhang on the stock.
Manufacturing issues at the company's other facilities, such as
at Lake Forest, McPherson, Austin and IKKT are further challenges
Hospira carries a Zacks Rank #5 (Strong Sell). Not all stocks in
the medical sector are performing as poorly as Hospira. Stocks
Edwards Lifesciences Corporation
) are well placed in the sector and carry a Zacks Rank #2