FDA Approves of Acticlate Tablets from Aqua Pharmaceuticals, LLC

The FDA approved Aqua Pharmaceuticals' Acticlate (doxycycline hyclate USP) Tablets, 150 mg and 75 mg, an 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, according to the company, 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, according to Aqua Pharmaceuticals.

“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.”

According to Dr. James Del Rosso, "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."

For more information and the Full Prescribing Information for Acticlate, please visit www.aquapharm.com.