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Kala Pharmaceuticals Announces New Drug Application for INVELTYSTM (KPI-121 1%) Has Been Accepted for Review by the U.S. Food and Drug Administration

KALA PHARMACEUTICALS (KALA)  More Company Research Source: Business Wire
US:NASDAQ Investor Relations: investors.kalarx.com
PDF - INVELTYS expected to be the first twice-daily ocular steroid indicated for the treatment of inflammation and pain following ocular surgery, if approved - - PDUFA target action date of August 24, 2018 - WALTHAM, Mass.--(BUSINESS WIRE)-- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the development and commercialization of product candidates using its proprietary mucus-penetrating particle (MPP) technology, today announced that the New Drug Application (NDA) for INVELTYSTM (KPI-121 1%), a topical twice-a-day product candidate for the treatment of inflammation and pain in patients who have undergone ocular surgery, has been accepted for review by the United States Food and Drug Administration (FDA). The FDA, in its 74-day letter, indicates that the application is sufficiently complete to permit a substantive review and has set a target action date under the Presc [Read more]

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