Enforcement Report - Week of February 7, 2024
CAMBRIDGE, Mass., Oct. 04, 2022 (GLOBE NEWSWIRE) -- Arbor Biotechnologies, a biotechnology company discovering and developing the next generation of genetic medicines, today announced that senior management will participate in a panel discussion and present a corporate overview at the 2022 Cell & Gene Meeting on the Mesa. The meeting will take place on October 11-13 in Carlsbad, California and will be livestreamed to attendees globally.
Global pharma major Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) azilsartan medoxomil tablets, 40 mg, and 80 mg to market a generic equivalent of Edarbi tablets, 40 mg, and 80 mg, of Arbor Pharmaceuticals, LLC.
Global pharma major Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) azilsartan medoxomil tablets, 40 mg, and 80 mg to market a generic equivalent of Edarbi tablets, 40 mg, and 80 mg, of Arbor Pharmaceuticals, LLC.
WOBURN, Mass. & ATLANTA--(BUSINESS WIRE)-- Azurity Pharmaceuticals, Inc. (“Azurity”) and Arbor Pharmaceuticals. (“Arbor”) today announced they have entered into a definitive agreement in which Azurity will be acquiring Arbor from existing investors including JW Asset Management and KKR. Following the completion of the transaction, which is subject to regulatory approvals, Azurity and Arbor will merge, creating a leading company offering innovative, high-value products to meet the unique needs of patients with underserved conditions. Financial details of the transaction were not disclosed.
Enforcement Report for Week of October 7, 2020
Arbor Pharmaceuticals, LLC, a US-based specialty pharmaceutical company, announced the presentation of positive safety and efficacy results from the pivotal phase 3 study in adults of AR19, its investigational immediate-release, amphetamine sulfate capsule for the treatment of attention-deficit/hyperactivity disorder (ADHD). AR19 is currently under review by the US Food and Drug Administration (FDA) as a potential ADHD treatment specifically designed to resist manipulation for non-oral use (i.e., snorting, smoking and injecting).
Arbor Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company, announced today the presentation of positive safety and efficacy results from the pivotal Phase 3 study in adults of AR19, its investigational immediate-release, amphetamine sulfate capsule for the treatment of attention-deficit/hyperactivity disorder (ADHD). AR19 is currently under review by the U.S. Food and Drug Administration (FDA) as a potential ADHD treatment specifically designed to resist manipulation for non-oral use (i.e., snorting, smoking and injecting). Researchers are presenting the study findings at the 33rd annual Psych
ATLANTA, Aug. 25, 2020 /PRNewswire/ -- Arbor Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company, today affirmed the full availability of Triptodur® (triptorelin), a twice yearly injectable gonadotropin releasing hormone agonist (GnRHa) for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).1 The company confirmed that it has ample supply and also announced it had ordered additional product from their manufacturing partner, Debiopharm, in response to reports of an industry shortage in the United States for a different injection product.
ATLANTA, Aug. 25, 2020 /PRNewswire/ -- Arbor Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company, today affirmed the full availability of Triptodur® (triptorelin), a twice yearly injectable gonadotropin releasing hormone agonist (GnRHa) for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).1 The company confirmed that it has ample supply and also announced it had ordered additional product from their manufacturing partner, Debiopharm, in response to reports of an industry shortage in the United States for a different injection product.