BRIDGEWATER, N.J., Oct. 25, 2018 /PRNewswire/ — Impax Laboratories LLC (the “Company”), a accessory of Amneal Pharmaceuticals, Inc. (AMRX), today appear that in accord with the U.S. Food and Biologic Administration (FDA), the Aggregation is extending the cessation dates for assertive lots of its epinephrine injection, USP auto-injector, 0.15 mg and 0.3 mg, the accustomed all-encompassing of Adrenaclick®.
Based on the medical alarm of epinephrine auto-injector and to abetment with any shortages, the cessation date for specific lots will be added from 18 months to 20 months. By accepting use of assertive lots of epinephrine injection, USP auto-injector for two months above their labeled cessation dates, the FDA seeks to ensure able accumulation of epinephrine articles in the marketplace. To advice ensure accommodating safety, the FDA advises that food of epinephrine injection, USP auto-injector should accept been – and should abide to be – stored as labeled.
The afflicted lots are listed in the afterward table alternating with their adapted cessation dates. This advice can additionally be begin on FDA’s website at https://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm and on Impax Epinephrine Auto-injector website at https://epinephrineautoinject.com.
About Epinephrine Injection, USP Auto-Injector
Epinephrine injection, USP auto-injector (also alleged epinephrine auto-injector) is an emergency bang (shot) of epinephrine acclimated for the analysis of life-threatening allergic reactions accepted as anaphylaxis. Before you use the epinephrine auto-injector, acquaint your healthcare provider about all your medical conditions. With numbered and color-coded instructions, epinephrine auto-injector is advised for single-dose use by patients and caregivers in an anaphylactic emergency and does not booty the abode of emergency medical care. Afterwards application epinephrine autoinjector go to your doctor or emergency allowance appropriate abroad for added medical treatment. For abounding Prescribing Advice see http://epinephrineautoinject.com/pdf/Prescribing-Information.pdf. For added advice about epinephrine injection, USP auto-injector, ask your doctor or alarm 1-888-894-6528.
Safe Anchorage Statement
Certain statements independent herein, apropos affairs that are not absolute facts, may be advanced statements (as authentic in Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended). We intend such advanced statements to be covered by the safe anchorage accoutrement for advanced statements independent in the Private Securities Action Ameliorate Act of 1995 and accommodate this account for purposes of acknowledging with the safe anchorage provisions. Such advanced statements accommodate statements apropos management’s intentions, plans, beliefs, expectations or forecasts for the future. The words such as “may,” “will,” “could,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “continue,” and agnate words are advised to analyze estimates and advanced statements. Such advanced statements are based on the expectations of Amneal Pharmaceuticals, Inc. (“our” or the “Company”) and absorb risks and uncertainties; consequently, absolute after-effects may alter materially from those bidding or adumbrated in the statements. Such risks and uncertainties include, but are not bound to (i) our adeptness to accommodate the operations of Amneal Pharmaceuticals LLC (“Amneal”) and Impax Laboratories, Inc. (“Impax”) pursuant to the affairs (the “Combination”) advised by that assertive Business Combination Acceding anachronous as of October 17, 2017 by and amid the Company, Amneal, Impax and K2 Merger Sub Corporation as adapted by Amendment No. 1, anachronous November 21, 2017 and Amendment No. 2 anachronous December 16, 2017 and our adeptness to apprehend the advancing synergies and added allowances of the Combination, (ii) the actuality that assertive of our stockholders captivation over a majority of our shares may accept interests altered from those of our added stockholders, (iii) the transaction costs accompanying to the Combination, (iv) after-effects from the accessible unaudited banking advice of Impax and Amneal may not be apocalyptic of the Company’s approaching operating performance, (v) business issues faced by either Amneal or Impax may be accepted to the operations of the Company, (vi) the appulse of a break of Impax or Amneal as a accessory of the Company, (vii) the change of ascendancy or aboriginal abortion rights in assertive of Impax’s or Amneal’s affairs that may be active by the Combination, (viii) payments appropriate by the Company’s Tax Receivables Agreement, (ix) the appulse of all-around bread-and-er conditions, (x) our adeptness to auspiciously advance or commercialize new products, (xi) our adeptness to access absolute business rights for our articles or to acquaint articles on a appropriate basis, (xii) the antagonism we face in the biologic industry from cast and all-encompassing biologic artefact companies, (xiii) our adeptness to administer our growth, (xiv) the appulse of competition, (xv) the actionable administration and auction by third parties of affected versions of our articles or of baseborn products, (xvi) bazaar perceptions of us and the assurance and affection of our products, (xvii) the abundant allocation of our absolute revenues acquired from sales of a bound cardinal of products, (xviii) our adeptness to develop, authorization or access and acquaint new articles on a appropriate basis, (xix) the adeptness of our accustomed articles to accomplish accepted levels of bazaar acceptance, (xx) the accident that we may abandon the accomplish and administration of assertive absolute products, (xxi) the appulse of accomplishment or affection ascendancy problems, (xxii) artefact accountability risks, (xxiii) risks accompanying to changes in the authoritative environment, including United States federal and accompaniment laws accompanying to healthcare artifice corruption and bloom advice aloofness and aegis and changes in such laws, (xxiv) changes to FDA artefact approval requirements, (xxv) risks accompanying to federal adjustment of arrange amid manufacturers of branded and all-encompassing products, (xxvi) the appulse of healthcare reform, (xxvii) business interruptions at one of our few locations that aftermath the majority of our products, (xxviii) relationships with our above customers, (xxix) the continuing trend of alliance of assertive chump groups, (xxx) our assurance on assertive licenses to proprietary technologies, (xxxi) our assurance on third affair suppliers and distributors for raw abstracts for our products, (xxxii) the time all-important to advance all-encompassing and branded biologic products, (xxxiii) our assurance on third parties for testing appropriate for authoritative approval of our products, (xxxiv) our assurance on third affair agreements for a allocation of our artefact offerings, (xxxv) our adeptness to accomplish acquisitions of or investments in commutual businesses and products, (xxxvi) authoritative blank in all-embracing markets, (xxxvii) our added acknowledgment to tax liabilities and the appulse of contempo United Accompaniment tax legislation, (xxxviii) third parties’ contravention of our bookish acreage rights, (xxxix) our captivation in assorted acknowledged proceedings, (xl) added government analysis accompanying to our agreements to accomplish apparent litigation, (xli) the appulse of legal, authoritative and aldermanic strategies by our cast competitors, (xlii) the cogent bulk of assets we expend on analysis and development, (xliii) our abundant bulk of indebtedness, (xliv) risks inherent in administering analytic trials, (xlv) our advertisement and acquittal obligations beneath the Medicaid and added government abatement programs, (xlvi) fluctuations in our operating results, (xlvii) adjustments to our affluence based on bulk adjustments and sales allowances, (xlviii) appulse of crime on our amicableness and added abstract assets, (xlix) investigations and action apropos the adding of boilerplate ample prices, (l) cybersecurity and abstracts arising risks, (li) our adeptness to allure and absorb accomplished advisers and consultants, (lii) uncertainties circuitous in the alertness of our banking statements, (liii) appulse of agitator attacks and added acts of violence, (liv) amplification of amusing media platforms, (lv) our charge to accession added funds in the future, (lvi) the restrictions imposed by the acceding of our acclaim agreement, (lvii) our adeptness to accomplish acceptable banknote to account our acknowledgment in the approaching and (lviii) such added factors as may be set alternating in the Company’s accessible filings with the Securities and Exchange Commission.
Forward-looking statements included herein allege alone as of the date hereof and we undertake no obligation to alter or amend such statements to reflect contest or affairs afterwards the date hereof or to reflect the accident of hasty contest or circumstances.
About Amneal Pharmaceuticals, Inc.
Amneal Pharmaceuticals, Inc. (AMRX), headquartered in Bridgewater, NJ, is an chip specialty biologic aggregation focused on developing, accomplishment and distributing generic, cast and biosimilar products. The Aggregation has about 6,500 advisers in its operations in North America, Asia, and Europe, alive calm to accompany high-quality medicines to patients primarily aural the United States.
Amneal is one of the better and fastest growing all-encompassing biologic manufacturers in the United States, with an accretion portfolio of all-encompassing articles to accommodate circuitous dosage forms in a ample ambit of ameliorative areas. The Aggregation markets a portfolio of branded biologic articles through its Impax Specialty Pharma analysis focused principally on axial afraid arrangement disorders and abject infections. For added information, visit www.amneal.com.
Contact:Mark DonohueInvestor Relations and Corporate Communications (908) 409-6718 www.amneal.com
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