18/04/2019 22:00:00

Akorn Receives FDA Approval for Loteprednol Etabonate Ophthalmic Suspension, 0.5%

LAKE FOREST, Ill., April 18, 2019 (GLOBE NEWSWIRE) -- Akorn, Inc. (Nasdaq: AKRX), a leading specialty generic pharmaceutical company, today announced that it received a new Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for Loteprednol Etabonate Ophthalmic Suspension, 0.5%. The product is manufactured at Akorn’s Amityville, New York manufacturing facility.

Douglas Boothe, Akorn’s President and Chief Executive Officer, stated, “This is a really exciting approval for Akorn as we believe it is a first generic approval for loteprednol suspension and it highlights our ability to execute on development and manufacturing of complex ophthalmic suspensions.  I’m also pleased that we are in the final stages of preparing for commercial launch.”

According to IQVIA, U.S. sales of Loteprednol Etabonate Ophthalmic Suspension, 0.5% were approximately $89 million for the twelve months ended February 2019.

Loteprednol Etabonate Ophthalmic Suspension, 0.5% is indicated for the treatment of post-operative inflammation following ocular surgery and the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.  

About Akorn

Akorn, Inc. is a specialty generic pharmaceutical company engaged in the development, manufacture and marketing of multisource and branded pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois; Somerset, New Jersey; Amityville, New York; Hettlingen, Switzerland and Paonta Sahib, India that manufacture ophthalmic, injectable and specialty sterile and non-sterile pharmaceuticals. Additional information is available on Akorn’s website at www.akorn.com.

Cautionary Note Regarding Forward-Looking Statements

This press release includes statements that may constitute "forward-looking statements", including expectations and other statements regarding Akorn's commercial launch timing, and other goals and plans. When used in this document, the words “will,” “expect,” “continue," “scheduled,” “plans,” “intend,” and similar expressions are generally intended to identify forward-looking statements. These statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. A number of important factors could cause actual results of Akorn and its subsidiaries to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to: (i) the effect of the Delaware court’s recent decision against Akorn on Akorn’s ability to retain and hire key personnel, its ability to maintain relationships with its customers, suppliers and others with whom it does business, or its operating results and business generally, (ii) the risk that ongoing or future litigation related to the court’s decision may result in significant costs of defense, indemnification and/or liability, (iii) the outcome of the investigation conducted by Akorn with the assistance of outside consultants, into alleged breaches of FDA data integrity requirements relating to product development at Akorn and any actions taken by Akorn, third parties or the FDA as a result of such investigations, (iv) the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any, (v) the timing and success of product launches, (vi) difficulties or delays in manufacturing, and (vii) such other risks and uncertainties outlined in the risk factors detailed in Part I, Item 1A, “Risk Factors,” of Akorn’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018 (as filed with the Securities and Exchange Commission (“SEC”) on March 1, 2019), and other risk factors identified from time to time in our filings with the SEC. Readers should carefully review these risk factors, and should not place undue reliance on our forward-looking statements. These forward-looking statements are based on information, plans and estimates at the date of this report. Akorn undertakes no obligation to update any forward-looking statements to reflect changes in underlying assumptions or factors, new information, future events or other changes.

Investors/Media:

(847) 279-6162

Investor.relations@akorn.com

AkornLogoSOLID_.jpg

Del

Post comment

Related debate

  • 1 week
  • 1 month
  • 1 Year
17 Sep
CHEMM
Mullen jeg tror du hænger meget fast i hvordan markedet så ud for ½ år tilbage. Vi har i mellemtiden..
38
18 Sep
DANSKE
Her er lidt om de Berlingske løgnhistorier o Danske Bank - for det tilfælde I har lyst til at anlægg..
29
17 Sep
 
Kære EI,   Jeg har stor forståelse for at i skal tjene penge, for at kunne ove ville udbyde de ydels..
23
22 Sep
OMXC25
Har scannet C25 aktierne igennem og fundet nogle ting som jeg vil være på udkig efter den kommende t..
20
18 Sep
DANSKE
Hvor er dog dejligt at der er en journalist der går lidt dybere og ser hvad journalistik kan bruges ..
16
00:58
VELO
Velkommen til ugens faste tråd om Veloxis & Envarsus 😊   Intet nyt. Vi venter nok alle på afslutni..
14
19 Sep
DANSKE
ref 417838   Det er jo bare endnu en ubegavet journalist fra Berlingeren, der ikke ved en dyt om, Ja..
13
20 Sep
VWS
Mon ikke lige vi skal spise brød til, inden vi konkluderer af GE løber med sejren. De har end ikke d..
12
21 Sep
 
Håber dette er okay for admin Nordnet og deres fusk - meld dig ind og fortæl din historie Det..
11
18 Sep
DANSKE
INVESTOR1 : Jeg tror blot vi aktionærer i Danske Bank, er lidt mere vel afbalanceret som helhed. Vi ..
11

#

EuroInvestor: In Focus
#

#

EuroInvestor: In Focus
#

#

EuroInvestor: In Focus
#

Most read news

  • 24 hours
  • 48 hours
  • 1 week
1
Oncology Venture presents positive data at ESMO on DRP as   a response predictor for 5-FU treatment in colorectal cancer
2
BeiGene Announces Clinical Results on Tislelizumab Presented at the 22nd Annual Meeting of the Chinese Society of Clinical Oncology (CSCO)
3
Finisar Presents Industry-First Optical Communication Solutions Driving Next-Generation Data Centers and Carrier Networks at ECOC 2019
4
Youth INC and RBC Gather Thousands to Raise $1.7 Million for New York City Youth
5
5-DAY DEADLINE ALERT: The Schall Law Firm Announces the Filing of a Class Action Lawsuit Against 3M Company and Encourages Investors with Losses in Excess of $100,000 to Contact the Firm

Latest news


Copyright Berlingske Media 2019  Cookie- and Privacy policy  |  Cookies  |   General terms of trade  |   Terms of use and IP rights
Quote information is delivered by Morningstar.
Data is delayed 15-20 minutes according to the distribution agreements set by the different exchanges.
 
23 September 2019 13:03:24
(UTC+00:00) Dublin, Edinburgh, Lisbon, London
Version: LiveBranchBuild_20190829.2 - EUROWEB1 - 2019-09-23 14:03:24 - 2019-09-23 13:03:24 - 1000 - Website: OKAY