Akorn, Inc. (NASDAQ:AKRX) Files An 8-K Regulation FD DisclosureItem 7.01. Regulation FD Disclosure.
On October 10, 2018, Akorn, Inc. (Nasdaq: AKRX), a leading specialty generic pharmaceutical company, announced that it has received a new Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for Bimatoprost Ophthalmic Solution, 0.03%. The product is manufactured at Akorn’s Amityville, New York manufacturing facility.
According to IQVIA, sales of bimatoprost ophthalmic solution, 0.03% were approximately $63.5 million for the twelve months ended August 2018.
Bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.
A copy of the press release is furnished as Exhibit 99.1 to this report.
The information in this Item 7.01, including exhibit 99.1 attached hereto, shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. See attached exhibit index.
AKORN INC ExhibitEX-99.1 2 exh_991.htm PRESS RELEASE EdgarFilingEXHIBIT 99.1Akorn Receives Product Approval LAKE FOREST,…To view the full exhibit click
About Akorn, Inc. (NASDAQ:AKRX)
Akorn Inc., together with its subsidiaries, is a specialty pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals, as well as private-label over-the-counter (OTC) consumer health products and animal health pharmaceuticals. The Company operates through two segments: Prescription Pharmaceuticals and the Consumer Health. The Prescription Pharmaceuticals segment is engaged in manufacturing and marketing generic and branded prescription pharmaceuticals, including ophthalmics, injectables, oral liquids, otics, topical, inhalants and nasal sprays. The Consumer Health segment is engaged in manufacturing and marketing branded and private-label animal health and OTC products. The Company’s Akorn Consumer Health division (ACH) markets a portfolio of OTC brands and various formulations of private-label OTC pharmaceutical products. Its OTC brand is TheraTears Therapy for Your Eyes, which is a family of therapeutic eye care products.