BUENA, N.J., Jan. 3, 2017 /PRNewswire/ -- Teligent, Inc.
(NASDAQ: TLGT), a New Jersey-based
specialty generic pharmaceutical company, today announced it has
received approval of three of the Company's abbreviated new drug
applications (ANDAs) from the U.S. Food and Drug Administration
(FDA) of Nystatin and Triamcinolone Acetonide Ointment USP, 100,000
units/gram and 1 mg/gram, Clindamycin Phosphate Topical Solution
USP, 1% and Flurandrenolide Ointment USP, 0.05%. These
approvals were received on December 30,
2016 and brings Teligent's total approvals from its
internally developed pipeline of topical generic pharmaceutical
products in 2016 to nine.
Based on recent IMS Health data from November 2016, the total addressable market for
these three products is approximately $73.6
million.
"Teligent received FDA approval for all three of these ANDAs on
the last day of 2016, which marks a tremendous completion to a
strong year for our team,'' commented Jason
Grenfell-Gardner, President and CEO of the Company. "In
addition, our partner received approval for Flurandrenolide Lotion
USP, 0.05%, a product we developed and submitted for them and we
anticipate manufacturing that product for our partner in the coming
weeks. We now have twenty FDA-approved specialty generic
prescription drug products in our domestic portfolio, evidencing
the continued successful implementation of our development and
diversification strategy. Just one year ago, our total
domestic portfolio was only eleven products. Our
commercialization team expects to launch all three of our new
products in the first quarter of 2017."
About Teligent, Inc.
Teligent is a specialty generic pharmaceutical company. Our
mission is to be a leading player in the specialty generic
prescription drug market. Learn more on our website
www.teligent.com.
Forward-Looking Statements
This press release includes certain "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements include, but are not
limited to, plans, objectives, expectations and intentions, and
other statements contained in this press release that are not
historical facts and statements identified by words such as "plan,"
"believe," "continue," "should" or words of similar meaning.
Factors that could cause actual results to differ materially from
these expectations include, but are not limited to: our inability
to meet current or future regulatory requirements in connection
with existing or future ANDAs; our inability to achieve
profitability; our failure to obtain FDA approvals as anticipated;
our inability to execute and implement our business plan and
strategy; the potential lack of market acceptance of our products;
our inability to protect our intellectual property rights; changes
in global political, economic, business, competitive, market and
regulatory factors; and our inability to complete successfully
future product acquisitions. These statements are based on our
current beliefs or expectations and are inherently subject to
various risks and uncertainties, including those set forth under
the caption "Risk Factors" in Teligent, Inc.'s most recent Annual
Report on Form 10-K, Quarterly Reports on Form 10-Q and other
periodic reports we file with the Securities and Exchange
Commission. Teligent, Inc. does not undertake any obligation
to update any forward-looking statements contained in this document
as a result of new information, future events or otherwise, except
as required by law.
Contact:
Jenniffer Collins
Teligent, Inc.
(856) 697-4379
www.teligent.com
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SOURCE Teligent, Inc.