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 to swallow."