Orange Book

Harrow Announces U.S. FDA Approval of IHEEZO™ (Chloroprocaine Hydrochloride Ophthalmic Gel) 3% for Ocular Surface Anesthesia

Retrieved on: 
Wednesday, September 28, 2022

NASHVILLE, Tenn. and MENDRISIO, Switzerland, September 28, 2022 /PRNewswire/ -- Harrow (Nasdaq: HROW), an eyecare pharmaceutical company exclusively focused on the discovery, development, and commercialization of innovative ophthalmic therapies, and Sintetica, S.A., a growing pharmaceutical company focused on analgesics, local anesthetics, and sterile injectable solutions, today jointly announced the U.S. Food and Drug Administration (FDA) approval of IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia. IHEEZO is a sterile, single-patient-use, physician-administered, ophthalmic gel preparation, containing no preservatives, that is safe and effective for ocular surface anesthesia. IHEEZO represents the first approved use in the U.S. ophthalmic market of chloroprocaine hydrochloride and the first branded ocular anesthetic approved for the U.S. ophthalmic market in nearly 14 years. IHEEZO is protected by an Orange Book-listed patent that is valid until 2038.

Key Points: 
  • IHEEZORepresentstheFirstApproved UseintheU.S.OphthalmicMarket of Chloroprocaine Hydrochloride and the First Branded Ocular Anesthetic Approved for the U.S. Ophthalmic Market in Nearly 14 Years
    IHEEZO was Licensed by Harrow for the U.S. and Canadian Markets From100-Year-OldInternationalPharmaceuticalCompanySintetica,S.A.
  • IHEEZO represents the first approved use in the U.S. ophthalmicmarketof chloroprocaine hydrochloride and the first branded ocular anesthetic approved for the U.S. ophthalmic market in nearly 14 years.
  • IHEEZO is protected by an Orange Book-listed patent that is valid until 2038.
  • Iwanttogivespecial thankstoourregulatorygroup, who while working with the Harrow team, performed extraordinarily well, resulting in this early U.S. market approval for this important new medicine."

Harrow Announces U.S. FDA Approval of IHEEZO™ (Chloroprocaine Hydrochloride Ophthalmic Gel) 3% for Ocular Surface Anesthesia

Retrieved on: 
Wednesday, September 28, 2022

NASHVILLE, Tenn. and MENDRISIO, Switzerland, September 28, 2022 /PRNewswire/ -- Harrow (Nasdaq: HROW), an eyecare pharmaceutical company exclusively focused on the discovery, development, and commercialization of innovative ophthalmic therapies, and Sintetica, S.A., a growing pharmaceutical company focused on analgesics, local anesthetics, and sterile injectable solutions, today jointly announced the U.S. Food and Drug Administration (FDA) approval of IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia. IHEEZO is a sterile, single-patient-use, physician-administered, ophthalmic gel preparation, containing no preservatives, that is safe and effective for ocular surface anesthesia. IHEEZO represents the first approved use in the U.S. ophthalmic market of chloroprocaine hydrochloride and the first branded ocular anesthetic approved for the U.S. ophthalmic market in nearly 14 years. IHEEZO is protected by an Orange Book-listed patent that is valid until 2038.

Key Points: 
  • NASHVILLE, Tenn. and MENDRISIO, Switzerland, September 28, 2022 /PRNewswire/ -- Harrow (Nasdaq: HROW), an eyecare pharmaceutical company exclusively focused on the discovery, development, and commercialization of innovative ophthalmic therapies, and Sintetica, S.A., a growing pharmaceutical companyfocused onanalgesics,localanesthetics,andsterileinjectablesolutions,todayjointly announced the U.S. Food and Drug Administration (FDA) approval of IHEEZO (chloroprocaine hydrochloride ophthalmicgel)3%forocularsurface anesthesia.IHEEZOisasterile, single-patient-use, physician-administered,ophthalmicgelpreparation,containingnopreservatives,thatissafeandeffective for ocular surface anesthesia.
  • IHEEZO represents the first approved use in the U.S. ophthalmicmarketof chloroprocaine hydrochloride and the first branded ocular anesthetic approved for the U.S. ophthalmic market in nearly 14 years.
  • IHEEZO is protected by an Orange Book-listed patent that is valid until 2038.
  • Iwanttogivespecial thankstoourregulatorygroup, who while working with the Harrow team, performed extraordinarily well, resulting in this early U.S. market approval for this important new medicine."

Harrow Announces U.S. FDA Approval of IHEEZO™ (Chloroprocaine Hydrochloride Ophthalmic Gel) 3% for Ocular Surface Anesthesia

Retrieved on: 
Tuesday, September 27, 2022

IHEEZO is a sterile, single-patientuse, physicianadministered, ophthalmic gel preparation, containing no preservatives, that is safe and effective for ocular surface anesthesia.

Key Points: 
  • IHEEZO is a sterile, single-patientuse, physicianadministered, ophthalmic gel preparation, containing no preservatives, that is safe and effective for ocular surface anesthesia.
  • IHEEZO represents the first approved use in the U.S. ophthalmic market of chloroprocaine hydrochloride and the first branded ocular anesthetic approved for the U.S. ophthalmic market in nearly 14 years.
  • Study 3 marks the first time a U.S. drug candidate was studied in a surgical model for FDA approval in the ocular surface anesthesia category.
  • Baum continued, Harrow currently provides perioperative medications for a significant number of the U.S. ophthalmic surgical procedures.

Evofem Announces Issuance of U.S. Patent Covering Phexxi® Composition of Matter

Retrieved on: 
Friday, September 23, 2022

SAN DIEGO, Sept. 23, 2022 /PRNewswire/ -- Evofem Biosciences (OTCPK: EVFM) today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,439,610, which covers the composition of matter of Phexxi® (lactic acid, citric acid, potassium bitartrate).  

Key Points: 
  • 11,439,610, which covers the composition of matter of Phexxi (lactic acid, citric acid, potassium bitartrate).
  • "We are extremely pleased with the continued development of the Phexxi patent portfolio, which comprises more than 40 patents.
  • Top-line data from EVOGUARD, Evofem's registrational Phase 3 clinical trial evaluating Phexxi for these two potential new indications, are expected in mid-October.
  • Evofem now has the sole right in the United States to make, have made, market, and sell for any commercial purpose the composition of matter that comprises Phexxi.

Newron provides H1 2022 results and updates on R&D and business activities

Retrieved on: 
Thursday, September 15, 2022

We also strengthened our senior leadership team and furthered our commitments to ESG standards, principles and outcomes.

Key Points: 
  • We also strengthened our senior leadership team and furthered our commitments to ESG standards, principles and outcomes.
  • In June 2022, Newron presented key scientific data of evenamide at the 33rd Collegium Internationale Neuro-Psychopharmacologicum (CINP) Hybrid World Congress of Neuropsychopharmacology, in Taipei, Taiwan.
  • Newron sees significant progress in the enrolment of patients for study 014 and expects to complete the process by the end of 2022, with results from the study due in QI/2023.
  • Filippo joined Newron in November 2016 as IT Director and became Director of Operations in January 2022.

DGAP-News: Newron provides H1 2022 results and updates on R&D and business activities

Retrieved on: 
Thursday, September 15, 2022

We also strengthened our senior leadership team and furthered our commitments to ESG standards, principles and outcomes.

Key Points: 
  • We also strengthened our senior leadership team and furthered our commitments to ESG standards, principles and outcomes.
  • In June 2022, Newron presented key scientific data of evenamide at the 33rd Collegium Internationale Neuro-Psychopharmacologicum (CINP) Hybrid World Congress of Neuropsychopharmacology, in Taipei, Taiwan.
  • Newron sees significant progress in the enrolment of patients for study 014 and expects to complete the process by the end of 2022, with results from the study due in QI/2023.
  • Filippo joined Newron in November 2016 as IT Director and became Director of Operations in January 2022.

Amryt Announces New Patent for Mycapssa®

Retrieved on: 
Tuesday, September 13, 2022

DUBLIN, Ireland, and Boston MA, September 13, 2022 Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, announces an update regarding the patents for its product Mycapssa (octreotide).

Key Points: 
  • DUBLIN, Ireland, and Boston MA, September 13, 2022 Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, announces an update regarding the patents for its product Mycapssa (octreotide).
  • The USPTO has issued to Amryt US Patent No.
  • Amryt has nine Orange Book-listed patents for Mycapssa with patent protection through December 2040.
  • Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases.

Bausch Health Responds to Norwich Pharmaceuticals Tentative FDA Approval for a 200 mg Rifaximin

Retrieved on: 
Friday, September 9, 2022

LAVAL, QC, Sept. 9, 2022 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) ("the Company"), and its gastroenterology business Salix Pharmaceuticals, today responded to the U.S. Food and Drug Administration's (FDA) tentative approval of the Norwich Pharmaceuticals rifaximin 200 mg product.

Key Points: 
  • LAVAL, QC, Sept. 9, 2022 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) ("the Company"), and its gastroenterology business Salix Pharmaceuticals, today responded to the U.S. Food and Drug Administration's (FDA) tentative approval of the Norwich Pharmaceuticals rifaximin 200 mg product.
  • The FDA will therefore not grant full approval until the expiry of the last of the Company's Orange Book listed patents for the XIFAXAN (rifaximin) 200 mg product on July 24, 2029.
  • XIFAXAN 200 mg is indicated for travelers' diarrhea and currently contributes less than 1 percent of Salix revenues.
  • Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products.

Baudax Bio receives notice of allowance for U.S. Patent Application covering use of ANJESO® for the treatment of moderate to severe pain

Retrieved on: 
Monday, August 22, 2022

A Notice of Allowance is issued after the USPTO makes the determination that a patent should be granted from an application.

Key Points: 
  • A Notice of Allowance is issued after the USPTO makes the determination that a patent should be granted from an application.
  • The 095 Application emphasizes ANJESOs potential to treat moderate to severe pain while potentially reducing the use of rescue analgesics.
  • ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.
  • Baudax Bio markets ANJESO, the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain.

VFMCRP announces U.S. Court upholds validity of Velphoro® patent

Retrieved on: 
Monday, August 22, 2022

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced that the U.S. District Court for the District of Delaware issued a judgment in VFMCRPs favor regarding U.S. patent no.

Key Points: 
  • Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced that the U.S. District Court for the District of Delaware issued a judgment in VFMCRPs favor regarding U.S. patent no.
  • Currently, Velphoro is protected by multiple Orange Book listed patents which expire between May 2029 and May 2035.
  • View the full release here: https://www.businesswire.com/news/home/20220821005007/en/
    A further ANDA patent infringement lawsuit against Teva based on patents no.
  • CSL Vifor welcomes the decision by the U.S. District Court to uphold the patent validity of Velphoro which highlights the innovation and strength of our intellectual property, said Florian Jehle, Chief Executive Officer of VFMCRP.