Lannett Provides Product Development Update on Thalidomide Capsules
08 Outubro 2013 - 10:28AM
Business Wire
--Company Completes Key Step in Process to
Submit Product Application--
Lannett Company, Inc. (NYSE MKT: LCI) today announced that it
has successfully completed a key step in its effort to submit to
the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug
Application (ANDA) for Thalidomide Capsules. The company believes
that it continues to be on track to submit its ANDA for Thalidomide
Capsules by January 2014.
As part of its product development activities for Thalidomide
Capsules, Lannett commenced bio-equivalency studies in fasting and
fed conditions in healthy volunteers. The company reported that the
results of the study in the fasting condition, the more difficult
of the two conditions, met bio-equivalency requirements and, upon
successful completion of the study in the fed condition, it will
begin the process of assembling and filing its ANDA for submission
and review by the FDA. There can be no assurance if or when the FDA
will approve the company’s Thalidomide Capsules application. Using
an experienced outside consulting firm, Lannett also said it has
prepared a Risk Evaluation and Mitigation Strategies (REMS), an FDA
requirement to ensure that the benefits of its Thalidomide product
outweigh the risks.
Sales of Thalidomide Capsules at Average Wholesale Price (AWP)
were approximately $66 million for the second quarter 2013,
according to Celgene’s website. Distribution of Thalidomide is
controlled by the FDA because of the drug’s toxicity and risk of
severe, life threatening human birth defects.
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 completing bio-equivalency studies, submitting an ANDA
to the FDA by January 2014 and successfully commercializing
Thalidomide Capsules, 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.
Robert Jaffe Co., LLCRobert Jaffe, (424) 288-4098
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