Lannett Provides Product Development Update on Thalidomide Capsules

  Lannett Provides Product Development Update on Thalidomide Capsules

   --Company Completes Key Step in Process to Submit Product Application--

Business Wire

PHILADELPHIA -- October 8, 2013

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.

Contact:

Robert Jaffe Co., LLC
Robert Jaffe, (424) 288-4098
 
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