Lannett Company, Inc.
) recently announced that the US Food and Drug Administration (FDA)
granted approval to the company's abbreviated new drug application
(ANDA) for its generic version of
Watson Pharmaceuticals Inc.
) Fioricet (butalbital, acetaminophen and caffeine) tablets (50 mg,
325 mg and 40 mg).
Fioricet is currently approved for the relief of tension
headache. Lannett intends to start shipping its generic version in
As per IMS Health, total sales at average wholesale price (AWP)
of butalbital, acetaminophen and caffeine tablets amounted to
approximately $30 million for the twelve months ended July 31,
2012. Out of the total sales of $30 million, $15 million was
recorded from sales of branded Fioricet.
We note that this is not the company's first approved generic
associated with tension headache. Previously, the company had
gained approval for the generic version of Watson Pharma's Fiorinal
(butalbital, aspirin and caffeine capsules), which it distributes
Lannett specializes in the manufacturing, packaging, marketing
and distribution of generics. Lannett has generics for the
treatment of a wide range of diseases like obesity, thyroid, and
hypertension, among others.
Other generic launches at Lannett Company include Watson
Pharma's diuretic drug, Microzide and
We remind investors that the company currently has several
pending applications with the FDA, which includes quite a few
candidates targeting large markets.
In the last two fiscal years, Lannett has received approval for
ten ANDAs from the FDA. The company also expects to receive several
more approvals in the current fiscal year.
Currently, we have a Neutral recommendation on Lannet Company,
Inc. The stock carries a Zacks #3 Rank (short-term Hold
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