Le Lézard
Classified in: Health
Subjects: PDT, FDA, FVT

Perrigo Announces FDA Final Approval For Its AB Rated Generic Version Of DermOtic® Oil, 0.01% Ear Drops


DUBLIN, July 19, 2017 /PRNewswire/ -- Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing DermOtic® Oil, 0.01% Ear Drops (fluocinolone acetonide oil 0.01%). The Company anticipates launching this product within 90 days. 

Perrigo Company. (PRNewsFoto/Perrigo Company)

DermOtic® Oil, 0.01% Ear Drops are indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients two years old and older. Annual market sales for DermOtic® Oil, 0.01% Ear Drops for the 12 months ending May 2017 were approximately $26 million.

Perrigo Executive Vice President and President Rx Pharmaceuticals John Wesolowski stated, "Upon launch, this will be our fifth new product launched in 2017, these launches include the generic versions of Axiron®, Derma-Smoothe/FS® Scalp Oil, Derma-Smoothe/FS® Body Oil and Hycodan®. Bringing these new products to market illustrates the Rx team's commitment to providing affordable treatment options for patients in important extended topical categories."

About Perrigo

Perrigo Company plc, a leading global healthcare company, delivers value to its customers and consumers by providing Quality Affordable Healthcare Products®. Founded in 1887 as a packager of home remedies, Perrigo has built a unique business model that is best described as the convergence of a fast-moving consumer goods company, a high-quality pharmaceutical manufacturing organization and a world-class supply chain network. Perrigo is the world's largest manufacturer of over-the-counter ("OTC") healthcare products and supplier of infant formulas for the store brand market. The Company also is a leading provider of branded OTC products throughout Europe and the U.S., as well as a leading producer of "extended topical" prescription drugs. Perrigo, headquartered in Ireland, sells its products primarily in North America and Europe, as well as in other markets, including Australia, Israel and China. Visit Perrigo online at (http://www.perrigo.com).

Forward-Looking Statements

Certain statements in this press release are "forward-looking statements." These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or the negative of those terms or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company's control, including: the timing, amount and cost of any share repurchases; future impairment charges; the success of management transition; customer acceptance of new products; competition from other industry participants, some of whom have greater marketing resources or larger market shares in certain product categories than the Company does; pricing pressures from customers and consumers; potential third-party claims and litigation, including litigation relating to the Company's restatement of previously-filed financial information; potential impacts of ongoing or future government investigations and regulatory initiatives; general economic conditions; fluctuations in currency exchange rates and interest rates; the consummation of announced acquisitions or dispositions, and the Company's ability to realize the desired benefits thereof; the Company's ability to achieve its guidance; and the Company's ability to execute and achieve the desired benefits of announced cost-reduction efforts and other initiatives.  In addition, the Company may identify and be unable to remediate one or more material weaknesses in its internal control over financial reporting. Furthermore, the Company and/or its subsidiaries may incur additional tax liabilities in respect of 2016 and prior years as a result of any restatement or may be found to have breached certain provisions of Irish company legislation in respect of prior financial statements and if so may incur additional expenses and penalties. These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended December 31, 2016, as well as the Company's subsequent filings with the United States Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE Perrigo Company plc


These press releases may also interest you

at 10:30
The "Licensing Deals in Biotechnology 2019-2024" report has been added to ResearchAndMarkets.com's offering. Licensing Deals in Biotechnology provides a detailed understanding and analysis of how and why companies enter licensing deals. Fully...

at 10:30
The "Molecular Diagnostics for Cancer: Markets Forecasts by Cancer Type, Product, and Place with Executive & Consultant Guides and Customization. 2023 to 2027" report has been added to ResearchAndMarkets.com's offering. Exciting technical...

at 10:10
The group division of Ameritas proudly announces its 17th consecutive certification as a BenchmarkPortal Center of Excellence, solidifying its position as a leader in customer service and support excellence. This prestigious recognition for 2023...

at 10:05
The "Distribution Deals in Diagnostics 2016 to 2024" report has been added to ResearchAndMarkets.com's offering. Distribution Deals in Diagnostics provides a detailed understanding and analysis of how and why companies enter distribution deals....

at 10:00
Driving is the leading cause of work-related death each year in the United States, with nearly 40% of deaths on the job occurring on American roads according to the U.S. Bureau of Labor Statistics. A major contributing factor to road deaths each...

at 10:00
Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the recent launch of Methimazole Tablets, USP, 5 mg and 10 mg. The Methimazole Tablet market had U.S. sales of approximately $36.8 million for the 12 months ending December 2023 according...



News published on and distributed by: