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BRIDGEWATER, N.J., May 10, 2021 (GLOBE NEWSWIRE) RVL Pharmaceuticals, Inc., a subsidiary of Osmotica Pharmaceuticals plc (Nasdaq: OSMT) (“Osmotica”), a fully integrated biopharmaceutical company, today announced that its
® (oxymetazoline hydrochloride ophthalmic solution), 0.1% has been selected as the winner of the “Best New Technology Solution for Drug Delivery” award in the fifth annual MedTech Breakthrough Awards program conducted by
MedTech Breakthrough, an independent market intelligence organization that recognizes the top companies, technologies and products in the global health and medical technology market.
Upneeq
® provides patients and eye care providers with a safe and convenient non-surgical option to treat adults with acquired blepharoptosis (ptosis). The FDA-approved eye drop is the first and only therapeutic approved for the condition which previously required a surgical procedure. Upneeq
About Osmotica Pharmaceuticals plc
Osmotica Pharmaceuticals plc is a fully integrated biopharmaceutical company focused on the development and commercialization of specialty products that target markets with underserved patient populations. RVL Pharmaceuticals, Inc. is the Company s ophthalmic subsidiary supporting UPNEEQ. Vertical Pharmaceuticals, LLC represents the Company s diversified branded portfolio and Trigen Laboratories, LLC represents the Company s non-promoted products, including complex generic formulations.
Osmotica has operations in the United States, Argentina, and Hungary.
Investor and Media Relations for Osmotica Pharmaceuticals plc
Lisa M. Wilson
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Osmotica to Present at 10th Annual SVB Leerink Global Healthcare Conference
Osmotica Holdings US LLCFebruary 18, 2021 GMT
BRIDGEWATER, N.J., Feb. 18, 2021 (GLOBE NEWSWIRE) Osmotica Pharmaceuticals plc (Nasdaq: OSMT) (“Osmotica” or the “Company”), a fully integrated biopharmaceutical company, announced today that Brian Markison, Chief Executive Officer, and Andrew Einhorn, Chief Financial Officer, will present at the 10th Annual SVB Leerink Global Healthcare Conference as follows:
Date:
Webcast:
About Osmotica Pharmaceuticals plc Osmotica Pharmaceuticals plc (Nasdaq: OSMT) is a fully integrated biopharmaceutical company focused on the development and commercialization of specialty products that target markets with underserved patient populations. The company has a diverse portfolio consisting of promoted and non-promoted products, several of which incorporate Osmotica’s
Osmotica Pharmaceuticals plc Receives Complete Response Letter from U.S. Food and Drug Administration for Arbaclofen Extended Release Tablets Osmotica Holdings US LLC Bridgewater, New Jersey, UNITED STATES
BRIDGEWATER, N.J., Dec. 29, 2020 (GLOBE NEWSWIRE) Osmotica Pharmaceuticals plc (Nasdaq: OSMT) (“Osmotica” or the “Company”) today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter (“CRL”) regarding the Company s New Drug Application (“NDA”) seeking approval for the investigational agent arbaclofen extended release ( ER ) tablets to treat spasticity resulting from multiple sclerosis.
The CRL stated that the Company did not provide adequate justification (including in its most recent NDA amendment) for the statistical analysis of the change from baseline to Day 84 in TNmAS-MAL scores comparing arbaclofen 40 mg to placebo, one of the co-primary endpoints. The FDA made a number of reco