Fluorometholone

- Fluorometholone Ophthalmic Suspension, USP, 0.1% - Product has 180-day competitive generic therapy exclusivity BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced the approval and launch of fluorometholone ophthalmic suspension. The product received 180-day competitive generic therapy (CGT) exclusivity from the U.S. Food and Drug Administration, a status that applies to first-marketed generics of key medicines. FML® suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. “We are starting the new year with the launch of another complex high-value product, which will help drive our continued growth,” said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics. “Ophthalmic products represent a less crowded and more durable category, and we continue to expand our portfolio of affordable medicines.” Adverse drug events reported with the use of fluorometholone ophthalmic suspension 0.1% include short term inflammatory eye reactions such as eye and eyelid swelling, redness, burning eye pain, itchy eyes; and long-term use effects including elevation of intraocular pressure (IOP) with possible development of glaucoma, infrequent optic nerve damage, cataract formation, vision problems, and delayed eye wound healing. For full prescribing information, see package insert located here. According to IQVIA®, U.S. annual sales for FML for the 12 months ended November 2023 were approximately $62 million. About Amneal Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 270 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit . Cautionary Statement on Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations, including international expansion; expected or estimated operating results and financial performance; the Company’s growth prospects and opportunities as well as its strategy for growth; product development and launches; the successful commercialization and market acceptance of new products, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company. Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our ability to manage our growth through acquisitions and otherwise; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our ability to secure satisfactory terms when negotiating a refinancing or other new indebtedness; our dependence on third-party agreements for a portion of our product offerings; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties, including recent events affecting the financial services industry; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our ability to attract, hire and retain highly skilled personnel; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

THURSDAY, May 11, 2023 -- If you suffer from allergies, you know how bothersome and uncomfortable the sneezing and itchy eyes can be. These symptoms are more than irritating — they impact day-to-day activities like work, school, sports, sleeping and even eating. Not only that, but allergies can also cause more serious health problems such as asthma and even anaphylaxis, a life-threatening allergic reaction. Allergies are a common health condition affecting almost one-third of adults in the United States and just over one-quarter of children under 17, according to the U.S. Centers for Disease Control and Prevention . But there is relief at hand: Here’s what you need to know about the most common allergy medicines, the type of allergies they treat, how they work and common side effects. Antihistamines This type of allergy medicine is very effective in relieving allergy symptoms. Mayo Clinic explains this drug type works by blocking histamine, “a symptom-causing chemical released by your immune system during an allergic reaction.” Antihistamines are available as an over-the-counter medication or as a prescription allergy medicine, and they are sold in oral form, as a nasal spray or as eyedrops. This allergy medicine treats symptoms of indoor and seasonal allergies. Common side effects of antihistamines include drowsiness, dry mouth, dizziness, blurred or double vision, mucous thickening and low blood pressure. Common antihistamines include: Oral Loratadine (Alavert, Claritin) Cetirizine (Zyrtec) Diphenhydramine (Benadryl) Doxylamine (Vicks NyQuil, Tylenol Cold and Cough Nighttime) Fexofenadine (Allegra) Nasal spray Olopatadine (Patanase) Eyedrops Ketotifen (Zaditor) Leukotriene modifiers Leukotriene modifiers prevent or lessen the symptoms of allergic rhinitis (hay fever) and allergic asthma. The Cleveland Clinic explains that leukotrienes are chemicals released in the body when you come in contact with an allergen. This causes symptoms like a runny nose and coughing. Leukotriene inhibitors block the effects leukotrienes have on the body or “stop your body from producing them.” This allergy medicine treats symptoms of indoor and seasonal allergies. Leukotriene inhibitors can cause side effects such as cold or flu symptoms, headache, diarrhea, fatigue and itchy skin or rash. More serious side effects like depression, thoughts of suicide, hives, trouble breathing, vomiting and yellowing of the skin or eyes can occur. You should seek medical treatment in these cases. Common leukotriene inhibitors include: Montelukast (Singulair) Zafirlukast (Accolate) Zileuton (Zyflo) Corticosteroids Corticosteroids treat mild to severe allergy symptoms by reducing inflammation caused by your body’s reaction to an allergen. Corticosteroids are available in several forms including pills and liquids, nasal sprays, inhalers, creams and eyedrops. They treat allergic inflammation caused by indoor and seasonal allergens as well as insect stings. Severe allergic reactions are treated with oral corticosteroids, according to the Mayo Clinic. Side effects vary depending on the medication form, but can include increased blood glucose levels, high blood pressure, nosebleeds, mouth and throat irritation, and skin irritation. Common corticosteroids by form include: Pills and liquids Prednisolone (Prelone) Methylprednisolone (Medrol) Nasal sprays Budesonide (Rhinocort) Mometasone (Nasonex) Inhalers Fluticasone (Flovent) Mometasone (Asmanex Twisthaler) Creams Betamethasone (Dermabet, Diprolene) Desonide (Desonate, DesOwen) Eyedrops Fluorometholone (Flarex, FML) Loteprednol (Alrex, Lotemax) Immunotherapy Immunotherapy works by modifying the immune system and its reaction to allergens. It’s not used for immediate allergy symptom relief but is a long-term allergy treatment. Immunotherapy treatments (or allergy shots) are prescription medicines. "Allergy shots can be helpful for patients with seasonal and year-round allergies," Miranda Curtiss , an assistant professor at the University of Alabama at Birmingham School of Medicine, said in a recent article . "However, these are a long-term investment that require planning to continue therapy for three to five years for maximal benefit. Asthmatics who want to start allergy shots need to have their asthma under good control first before starting shots." With allergy shots, you are exposed to an allergen over and over until your immune system becomes desensitized and no longer reacts to the allergen, the Mayo Clinic says. This type of treatment is commonly given as allergy shots (subcutaneous immunotherapy, or SCIT), but is also available in a form given under the tongue (sublingual immunotherapy, or SLIT). With SCIT, injections are given in your doctor’s office where they can monitor for adverse reactions. Treatment starts with the “build-up phase,” which is once or twice a week, and decreases to a maintenance dose which is once every two to four weeks. Sublingual immunotherapy treatment, like subcutaneous immunotherapy, also exposes you to allergens over a period of time, with the goal of building immunity to the allergen. SLIT tablets are available by prescription and taken daily. Immunotherapy is used to treat seasonal and indoor allergies, as well as insect stings. Side effects include watery eyes, sneezing, mild asthma symptoms, a rash at the injection site, tiredness and headaches. In rare cases, life-threatening reactions such as throat swelling and difficulty breathing can occur. Regardless of the type of allergy or your symptoms, there are options for relief. Reach out to your health care provider to learn more about which remedies are best for you. Posted May 2023