PHILADELPHIA, June 26, 2017 /PRNewswire/ -- Lannett Company,
Inc. (NYSE: LCI) today announced that it received approval from the
U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug
Application (ANDA) for Hydrocodone Bitartrate and Acetaminophen
Tablets USP, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg, the
therapeutic equivalent to the reference listed drug,
Norco® Tablets, 5 mg/325 mg, 7.5 mg/325 mg, and 10
mg/325 mg, of Allergan Pharmaceuticals International Limited.
The product is also marketed under the brand name
Lortab® 5 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325
mg. For the 12 months ended April
2017, total U.S. sales of Hydrocodone Bitartrate and
Acetaminophen Tablets USP, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325
mg, at Average Wholesale Price (AWP) were approximately
$744.3 million, according to IMS.
"The dosage strengths approved by this ANDA currently represent
the lion's share of the market for Hydrocodone Bitartrate and
Acetaminophen Tablets and complement our already approved strengths
of 5 mg/300 mg, 7.5 mg/300 mg, and 10 mg/300 mg," said Arthur Bedrosian, chief executive officer of
Lannett. "New product approvals are the growth engine of
generic drug manufacturers. We have received four approvals
this month and five since the beginning of calendar 2017.
These approvals expand our pain management franchise and increase
the total number of products we offer to the marketplace. We
plan to launch all of our recently approved products in our new
fiscal year, which begins next week. With a number of drug
applications pending at the FDA, both our own filings and those of
our alliance partners, we believe additional approvals are
forthcoming."
About Lannett Company, Inc.:
Lannett Company, founded in 1942, develops, manufactures, packages,
markets and distributes generic pharmaceutical products for a wide
range of medical indications. For more information, visit the
company's website at www.lannett.com.
This news release contains certain statements of a
forward-looking nature relating to future events or future business
performance. Any such statement, including, but not limited
to, successfully commercializing Hydrocodone Bitartrate and
Acetaminophen Tablets USP, 5 mg/325 mg, 7.5 mg/325 mg, and 10
mg/325 mg, and the planned launch of recently approved products,
whether expressed or implied, is subject to market and other
conditions, and subject to risks and uncertainties which can cause
actual results to differ materially from those currently
anticipated due to a number of factors which include, but are not
limited to, the risk factors discussed in the Company's Form 10-K
and other documents filed with the SEC from time to time, including
the prospectus supplement related to the proposed offering to be
filed with the SEC. These forward-looking statements
represent the Company's judgment as of the date of this news
release. The Company disclaims any intent or obligation to
update these forward-looking statements.
Contact:
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Robert
Jaffe
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Robert Jaffe Co.,
LLC
|
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(424)
288-4098
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SOURCE Lannett Company, Inc.