Good news flowed in at
) when the U.S. Food and Drug Administration (FDA) cleared its
generic version of KV Pharmaceutical Company's vaginal cream
Gynazole·1. Final approval was granted by the U.S. regulatory body
for the local treatment of vulvovaginal candidiasis.
Apart from gaining FDA approval to sell its generic version of
the product, Perrigo also enjoys a six month marketing exclusivity
period regarding Gynazole·1 since it was the first company to file
an abbreviated new drug application (ANDA) with a para IV
certification for the drug. We remind investors that Perrigo filed
its ANDA with the FDA in 2010, seeking to sell its generic version
of the vaginal cream.
We note that KV Pharma stopped manufacturing the vaginal cream
in January 2009 owing to manufacturing issues. Following the FDA
approval, Perrigo is working with KV Pharma towards making the
generic version of Gynazole·1 available in the U.S. by
We note that this is the second piece of good news for Perrigo
from the FDA in a short span of time. Last week, the U.S.
regulatory body had cleared Perrigo's generic version of
) heart burn drug Prevacid. Approval was granted to treat patients
suffering from frequent heartburn (two or more days in a week).
Perrigo launched the drug in the U.S. following the receipt
of final approval from the FDA.
We note that the approval of the generic versions of Prevacid
and Gynazole·1 would be easy on the pockets of U.S. patients as
generic drugs are much cheaper than their branded counterparts.
We currently have a Neutral recommendation on Perrigo. The stock
carries a Zacks #3 Rank (short-term Hold rating).
We believe Perrigo has a sustainable and diversified product
portfolio. The company's strong position in the brand
over-the-counter pharmaceutical market and growing generics and
active pharmaceuticals ingredient (API) businesses are expected to
drive growth in the coming quarters. We are also impressed by
Perrigo's strong pipeline.
NOVARTIS AG-ADR (NVS): Free Stock Analysis
PERRIGO COMPANY (PRGO): Free Stock Analysis
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