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Aqua Pharmaceuticals, LLC Announces the U.S. Food and Drug Administration (FDA) Approval of ACTICLATE™ (doxycycline hyclate USP) Tablets, 150 mg and 75 mgWEST CHESTER, Pa. --(Business Wire)-- West Chester-based Aqua Pharmaceuticals, an Almirall company, today announces the U.S. Food and Drug Administration (FDA) approval of the NDA for ACTICLATE™ (doxycycline hyclate USP) Tablets, 150 mg and 75 mg, thereby continuing Aqua's leadership in medical dermatology and oral antibiotics for acne. ACTICLATE™ is a tetracycline-class antibacterial indicated for the treatment of a number of infections, including adjunctive therapy in severe acne. ACTICLATE™ will be entering the dermatology-focused, branded oral antibiotic market, which, according to IMS, is currently valued at $798 million. ACTICLATE™ 150 mg tablets have two functional scores, providing several dosing options to physicians and patients. The ACTICLATE™ film-coated, round 75 mg tablets and oval-shaped, dual-scored 150 mg tablets are designed to be small and easy to swallow. Utilization of the latest manufacturing technology has allowed 150 mg of doxycycline to be formulated in a substantially reduced tablet size for ACTICLATE™. "We are pleased to bring ACTICLATE™ to market," said Craig Ballaron, Chief Executive Officer at Aqua. "This launch represents our commitment to Aqua's continuing legacy of bringing high-quality, effective drugs to the dermatology specialty. We plan to begin detailing physicians on the benefits of ACTICLATE™ in the coming weeks." Aqua has already received positive feedback about the benefits of ACTICLATE™ from within the dermatology community. According to Dr. James Del Rosso, who is a recognized educator and researcher in dermatology that has been an invited lecturer both nationally and internationally on acne, has over 150 peer-reviewed publications, has co-edited a textbook on acne, and is Adjunct Clinical Professor of Dermatology at Touro University College of Osteopathic Medicine in Henderson, Nevada, "ACTICLATE™ is a new formulation of doxycycline that is a double-scored 150 mg tablet available in a much smaller tablet size than other available scored doxycycline tablets. This allows for dosing flexibility and may be easier for the patient o swallow." Important Safety Information Regarding ACTICLATE™ (doxycycline hyclate USP) Tablets, 150 mg and 75 mg
About Aqua Pharmaceuticals Headquartered in West Chester, Pennsylvania, Aqua Pharmaceuticals, an Almirall company, is dedicated to helping patients achieve their goals of healthy skin and a positive self-image. The company has leading branded prescription drugs in four therapeutic categories that include acne, steroid-responsive dermatoses, actinic keratoses and seborrheic dermatitis. For more information and the Full Prescribing Information for ACTICLATE™, please visit www.aquapharm.com. About Almirall Almirall is a global company based in Barcelona dedicated to providing valuable medicines through its R&D, agreements and alliances. Our work covers the whole of the drug value chain. A consolidated profitable growth allows us to devote our talent and efforts in the respiratory and dermatology areas, with a focused interest in gastroenterology and pain. Our size enables us to be agile and flexible so that we can accomplish the purpose of taking our innovative products wherever they are needed. Founded in 1943, Almirall is listed on the Spanish Stock Exchange (ticker: ALM) and it has become a source of value creation for society due to its vision and the commitment of its long-standing major shareholders. In 2013, its revenues totaled 825 million euros and, with more than 3,000 employees, it has gradually built up a trusted presence across Europe, as well as in the United States, Canada and Mexico. For more information, please visit www.almirall.com.
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