Teligent, Inc. Announces FDA Approval of Fluocinonide Cream USP, 0.1%
04 April 2019 - 11:54PM
Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic
pharmaceutical company, today announced it has received approval of
the Company’s abbreviated new drug application (ANDA) from the U.S.
Food and Drug Administration (FDA) of Fluocinonide Cream USP,
0.1%. This is Teligent’s fourth approval of 2019, and its
thirty-sixth approval from its internally-developed pipeline of
topical generic pharmaceutical medicines.
Based on recent IQVIA data from February 2019,
the total addressable market for this product is approximately
$17.3 million.
“Teligent continues to deliver on the promise of
our pipeline with this latest approval," commented Jason
Grenfell-Gardner, President and CEO of the Company. “This was a
first review cycle approval and was received ten months from
filing. The filing contained paragraph IV certifications, however
no action for infringement was brought against Teligent within the
statutory 45-day period and therefore we plan to launch this
product in the third quarter of 2019.”
Mr. Grenfell-Gardner continued, “We now have
forty topical generic pharmaceutical products in the US portfolio,
in addition to our four US injectable products.”
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.
Contact:
Damian Finio Teligent, Inc. 856-336-9117 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.
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