Salvat and arbor announce otovel (R) ear drops

Laboratorios salvat S.A (hereinafter referred to as "salvat") and arbor pharmaceuticals, LLC (hereinafter referred to as "arbor") jointly announced the launch of otovel (ciprofloxacin 0.3% and fluroxone 0.025%) ear drops This is the first and only combination ear drops of antibiotics and steroids, packaged in a single, sterile, preservative free unit dose Otovel is owned by salvat and arbor will be the exclusive distributor of the product in the United States Laboratorios salvat S.A and arbor pharmaceuticals, LLC jointly announced the launch of otovel (R) (ciprofloxacin 0.3% and fluxone 0.025%) ear drops Ed Schutter, President and CEO of arbor, said: "we are very pleased to work with salvat to sell otovel in the United States Otovel complements other pediatric products sold by our team of more than 200 sales specialists across the United States " Alberto Bueno, CEO of salvat, said: "we are very excited to work with arbor in the United States to further expand the international business scale of otovel As we continue to expand our influence in the U.S market, the new otovel is an important milestone for salvat " Brief introduction to otovel ® otovel ® (ciprofloxacin 0.3% and fluxone 0.025%) is used to treat acute otitis media (aomt) caused by infection of Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, catamoraxella and Pseudomonas aeruginosa in pediatric patients (children 6 months and above) In order to evaluate the efficacy and safety of otovel compared with ciprofloxacin ear drops and fluxone ear drops, two three-stage multicenter, randomized, double-blind, active control, parallel group trials were conducted The trial included 662 pediatric patients (6 months to 12 years old) with aomt In both trials, the stopping time of otovel group was significantly shorter than that of ciprofloxacin and fluxone group In Study 1 and 2, the median time to stop otorrhea in the otovel group was 3.75 days and 4.94 days, respectively Otovel ® is packaged in sterile disposable vials containing 0.25 ml of sterile, preservative free ear drops Otovel is promoted and distributed by arbor and is now sold nationwide in the United States Acute otitis media (aomt) acute otitis media (AOM) is an inflammation of the middle ear cavity behind the eardrum, usually caused by infection Infection often leads to fluid accumulation (effusion) in the middle ear, increasing the pressure of the eardrum This pressure can cause fever, earache and hearing problems in infected patients For children with recurrent acute otitis media, a small incision in the eardrum can be inserted into the tympanic tube to help the fluid flow out of the middle ear In the United States, about one million children receive catheterization every year Although catheterization may help reduce the recurrence of acute otitis media, recent studies have shown that 83% of children who have been catheterized for 18 months have had aomt at least once The clinical manifestations of aomt are different from those of acute otitis media in children with intact eardrum, and pain and fever are less common The most common symptom of aomt is ear drainage (otorrhea) Important safety information indication of otovel Otovel is used to treat aomt caused by infection of Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, catamoraxella and Pseudomonas aeruginosa in pediatric patients (children aged 6 months and above) Important safety information taboo otovel is forbidden to use in: patients who are known to be allergic to fluroxone or other corticosteroids, ciprofloxacin or other quinolones, or any other otovel ingredients Patients with external auditory tract virus infection, including varicella, herpes simplex virus infection and ear fungal infection Warning and precautions allergic reaction - when rash or other allergic reactions are found for the first time, otovel should be stopped immediately It has been reported that some patients have serious or even fatal allergic reactions after receiving quinolones for the first time Some allergic reactions are accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria and pruritus Severe acute allergic reactions may require immediate and urgent treatment Long term use may lead to over growth of microorganisms - long term use of otovel may lead to over growth of non sensitive bacteria and fungi If the infection does not improve after one week of treatment, strain culture should be done to guide further treatment If this infection occurs, it should be stopped immediately and alternative therapy should be studied Persistent or recurrent otorrhea - if the otorrhea persists after a full course of treatment, or occurs twice or more in six months, further evaluation is recommended to exclude potential diseases such as cholesteatoma, foreign bodies, or tumors Clinical trial experience of adverse reactions: the most common adverse reactions (occurred in more than one patient) include ear leakage, excessive granulation tissue, ear infection, ear pruritus, tympanic membrane disorders, auricular swelling and balance dysfunction For more safety information, please refer to otovel's complete product manual [provide E-Link to PI] About salvat laboratories salvat is an unlisted pharmaceutical group that pays close attention to technological innovation and is actively committed to research and development Founded in 1955, salvat is headquartered in Barcelona (Spain) and its US subsidiary salvat USA is located in Miami, Florida Salvat operates in more than 60 countries, and continues to expand its international reach through its own licensing of products In 2009, the company launched cetraxal (ciprofloxacin 0.2%) ear drops in the United States, and in April 2016, it was approved by FDA to launch otovel (ciprofloxacin 0.3% and fluxone 0.025%) ear drops For more information about laboratories salvat and its products, please visit http://www.salvatbiotechnology.com Arbor pharmaceuticals, headquartered in Atlanta, Georgia, is a professional pharmaceutical company focusing on the cardiovascular, hospital and pediatric markets With more than 600 employees, including 500 sales specialists, the company is committed to promoting its products to doctors, hospitals and pharmacists Arbor currently sells 20 products approved by NDA and anda, and more than 40 products are still under development For more information on arbor pharmaceuticals or any of its products, please visit http://www.arborpharma.com or email to info@arborpharma.com.