Otitis externa

Amneal Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension

Retrieved on: 
Monday, March 25, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, FDA, AOE, Otitis externa, Patient, Dexamethasone, Ciprofloxacin, Abbreviated New Drug Application, Pseudomonas aeruginosa, Medication, Infection, Staphylococcus aureus, Amneal Pharmaceuticals, Food

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension.
  • “This approval represents the addition of another complex, high value medicine,” said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics.
  • “It reflects the ongoing shift of our leading affordable medicines portfolio towards complex products and the continued successful diversification of our business.”
    The most common adverse reactions reported with ciprofloxacin and dexamethasone otic suspension were ear pain (2.3%), ear discomfort (3%), and ear pruritus (1.5%).
  • For full prescribing information, see package insert located here .

Brightly Announces Strategic Acquisition of Externa CGI, Elevating Visual Storytelling Capabilities

Retrieved on: 
Thursday, October 5, 2023
Partnership, Acquisition, Otitis externa, Creative director, MCSB

GRAND RAPIDS, Mich., Oct. 5, 2023 /PRNewswire/ -- Brightly, a boutique digital transformation studio, announced today that it has successfully acquired the award-winning 3D animation company Externa CGI. This acquisition is pivotal in broadening Brightly's portfolio with increased technical expertise and unique abilities anchored on animation, augmented reality (AR), and 3D visualization.

Key Points: 
  • "Our clients' success relies on us continually elevating our capabilities with services that complement our existing offerings and provide comprehensive solutions.
  • The strategic union between Brightly and Externa CGI marks a critical moment in our journey as a fully integrated digital transformation studio, bringing new opportunities and innovations to our clients," said Marion Siebert, Chief Experience Officer of Brightly.
  • Existing Externa CGI clients will now have access to Brightly's digital solutions as part of the acquisition.
  • Brightly continues to broaden its service offerings and penetrate new market segments, catalyzing its position as a leader in digital transformation solutions.

New Enhancements and Advancements in the Companion Animal Ear Infection Treatment Market 2023-2030 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, August 23, 2023
Pharmaceutical, Health, Veterinary, Cats and Dogs, Pressure, High, Research report, Block cipher mode of operation, Labyrinthitis, Dog, COVID-19, Consumer, Research, USD, Cat, Certification, Compound annual growth rate, Otitis externa, Social impact assessment, Investment, Quinolone antibiotic, Oral, R, Vaccine, Pharmaceutical industry, Pet industry, Topical medication, Aminoglycoside, Otitis media

The Cumulative Impact of COVID-19, the Russia-Ukraine Conflict, and High Inflation is expected to have significant long-term effects on the Global Companion Animal Ear Infection Treatment Market.

Key Points: 
  • The Cumulative Impact of COVID-19, the Russia-Ukraine Conflict, and High Inflation is expected to have significant long-term effects on the Global Companion Animal Ear Infection Treatment Market.
  • Which are the products/segments/applications/areas to invest in over the forecast period in the Global Companion Animal Ear Infection Treatment Market?
  • What is the market share of the leading vendors in the Global Companion Animal Ear Infection Treatment Market?
  • What modes and strategic moves are considered suitable for entering the Global Companion Animal Ear Infection Treatment Market?

MerLion Pharmaceuticals Completes Growth Financing Round

Retrieved on: 
Tuesday, May 18, 2021
Fluoroquinolone antibiotics, Chemical compounds, Drugs, Chemistry, Cyclopropanes, Finafloxacin, Nitriles, Otologicals, Ofloxacin, Quinolone antibiotic, Otitis externa, Merlion

\xe2\x80\x9cXtoro is an FDA-approved product for the treatment of Acute Otitis Externa in children and adults.

Key Points: 
  • \xe2\x80\x9cXtoro is an FDA-approved product for the treatment of Acute Otitis Externa in children and adults.
  • Its superior, fast acting properties will aid patients considerably in their recovery.\xe2\x80\x9d\nMerLion Pharmaceuticals GmbH is a is a privately held company biopharmaceutical company headquartered in Berlin, Germany.
  • MerLion is supported by a group of leading global investors.
  • For more information, please visit http://www.merlionpharma.com\nPOELLATH, Munich, Dr. Michael Inhester and Adalbert Makos advised MerLion on the investment and capital raise.\nFinafloxacin is a novel fluoroquinolone antibiotic with best-in-class features.

Groundbreaking New Product Ear Pro Launches in the U.S.

Retrieved on: 
Wednesday, April 14, 2021
Medical specialties, Otorhinolaryngology, Otitis, Pediatrics, Clinical medicine, Otitis externa, Ear, Audiology, Ear pain, Otitis media

It\'s quick and easy to spray in your ears and has no negative impact on your hearing or balance," said Ear Pro co-founder Tradian Maier.

Key Points: 
  • It\'s quick and easy to spray in your ears and has no negative impact on your hearing or balance," said Ear Pro co-founder Tradian Maier.
  • The two watermen knew they were on to something and after two years of research and testing, Ear Pro was created.
  • "Ear Pro provides a natural solution that promotes ear health and prevents acute otitis externa, thus decreasing antibiotic use.
  • Ear Pro is a 1% for the Planet company with 1% percent of all revenue going back to the planet to benefit a water-related cause.\n'

FTC Approves Final Order Requiring Animal Health Product Suppliers Elanco Animal Health, Inc. and Bayer Animal Health GmbH to Divest Assets in Three Product Markets as a Condition of Acquisition

Retrieved on: 
Friday, September 11, 2020
Companies, Health, Articles, Elanco, Neogen, Bayer, Nitenpyram, Otitis externa, Otitis, Divestment

Following a public comment period, the Federal Trade Commission has approved a final ordersettling charges that animal health products supplier Elanco Animal Health, Inc.s proposed $7.6 billion acquisition of Bayer Animal Health, Inc. would likely be anticompetitive.

Key Points: 
  • Following a public comment period, the Federal Trade Commission has approved a final ordersettling charges that animal health products supplier Elanco Animal Health, Inc.s proposed $7.6 billion acquisition of Bayer Animal Health, Inc. would likely be anticompetitive.
  • The final order requires Elanco to divest its canine otitis externa treatment, Osurnia, to Dechra Limited; its fast-acting oral treatment that kills adult fleas on dogs, Capstar, to PetIQ, LLC; and its brand name cattle pour-on insecticide, StandGuard, to Neogen Corporation.
  • Each divestiture requires Elanco to transfer all intellectual property and other related assets to the respective buyer.
  • The Commission vote to approve the final order was 4-0-1.

FTC Approves Final Order Requiring Animal Health Product Suppliers Elanco Animal Health, Inc. and Bayer Animal Health GmbH to Divest Assets in Three Product Markets as a Condition of Acquisition

Retrieved on: 
Friday, September 11, 2020
Companies, Health, Articles, Elanco, Neogen, Bayer, Nitenpyram, Otitis externa, Otitis, Divestment

Following a public comment period, the Federal Trade Commission has approved a final ordersettling charges that animal health products supplier Elanco Animal Health, Inc.s proposed $7.6 billion acquisition of Bayer Animal Health, Inc. would likely be anticompetitive.

Key Points: 
  • Following a public comment period, the Federal Trade Commission has approved a final ordersettling charges that animal health products supplier Elanco Animal Health, Inc.s proposed $7.6 billion acquisition of Bayer Animal Health, Inc. would likely be anticompetitive.
  • The final order requires Elanco to divest its canine otitis externa treatment, Osurnia, to Dechra Limited; its fast-acting oral treatment that kills adult fleas on dogs, Capstar, to PetIQ, LLC; and its brand name cattle pour-on insecticide, StandGuard, to Neogen Corporation.
  • Each divestiture requires Elanco to transfer all intellectual property and other related assets to the respective buyer.
  • The Commission vote to approve the final order was 4-0-1.

ALK Enters into Co-Promotion Agreement with Otonomy for OTIPRIO® (ciprofloxacin otic suspension), the First and Only Single-Dose Treatment for Acute Otitis Externa (Swimmer's Ear)

Retrieved on: 
Wednesday, June 17, 2020
Drugs, Medical specialties, RTT, Medicine, Fluoroquinolone antibiotics, Otologicals, Pediatrics, Otitis externa, Ciprofloxacin/dexamethasone, Ciprofloxacin, Pseudomonas aeruginosa, Otitis

"OTIPRIO provides an important option to treat patients, as young as six months old, with a single-dose antibiotic administered right in the doctor's office."

Key Points: 
  • "OTIPRIO provides an important option to treat patients, as young as six months old, with a single-dose antibiotic administered right in the doctor's office."
  • Acute otitis externa (AOE), also known as swimmer's ear, is a common condition involving infection and inflammation of the external ear canal typically caused by bacterial infection.
  • OTIPRIO is a sterile, preservative-free, otic suspension of 6 percent ciprofloxacin administered as a single-dose by a healthcare professional.
  • The treatment of acute otitis externa in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus.

InventHelp Presents Accessory to Clear Water from Ears (TRO-226)

Retrieved on: 
Thursday, April 9, 2020
Otitis, RTT, Medical specialties, Organ systems, Otitis externa, Pediatrics, Sensory systems, Ear

Approximately one in 123 persons yearly is affected by swimmer's ear in the United States.

Key Points: 
  • Approximately one in 123 persons yearly is affected by swimmer's ear in the United States.
  • The CDC recommends that whenever someone is around water, they keep their ears as dry as possible...with CLEAR-IT, now you can.
  • CLEAR-IT is patent-pending and offers an easy, fast and comfortable solution to remove water from the ears.
  • If used as soon as a person gets out of the water, it may help prevent getting an ear infection.

Glenmark Therapeutics Expands Specialty Portfolio with OTIPRIO® Co-Promotion Agreement in the U.S. with Otonomy for Acute Otitis Externa Indication

Retrieved on: 
Thursday, May 2, 2019
Bacteria, Medical specialties, Infectious diseases, RTT, Otitis, Otitis externa, Pediatrics, Glenmark, Pseudomonas aeruginosa, Staphylococcus aureus

Glenmark Therapeutics is dedicated to developing and commercializing a franchise of branded products for Glenmark Pharmaceuticals and is focused in the areas of respiratory and dermatology.

Key Points: 
  • Glenmark Therapeutics is dedicated to developing and commercializing a franchise of branded products for Glenmark Pharmaceuticals and is focused in the areas of respiratory and dermatology.
  • Financial terms for the multi-year agreement were not disclosed; however, Glenmark Therapeutics will provide Otonomy an annual co-promotion fee and provide reimbursement of a proportion of product support expenses.
  • In addition, Otonomy will retain a share of the adjusted gross profits from the sale of OTIPRIO to Glenmark's accounts.
  • The treatment of acute otitis externa in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus.