FDA tentatively approves generic Crestor
MUMBAI, India The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Sun Pharmaceutical Industries.
Sun announced Wednesday the tentative approval of rosuvastatin calcium tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths.
The drug is a generic version of AstraZeneca’s Crestor, which had annual sales of around $3.4 billion in the United States, according to Sun. Sun did not disclose when it would begin marketing its version of the drug, though Crestor will lose patent protection for use in adults in December 2021, according to FDA data.
Pharmacy groups launch e-health task force
WASHINGTON Staking a firm claim to the emerging technology revolution in health care, nine national pharmacy organizations Wednesday unveiled a new, joint task force to grapple with the challenges and opportunities posed by information technology.
The so-called Pharmacy e-Health Information Technology Collaborative will focus on the pharmacy profession’s technology needs “to ensure that they are addressed and integrated into the framework of the U.S. health information technology infrastructure,” the groups noted in a joint statement. “In doing so, the collaborative is committed to creating a comprehensive and unified approach, ensuring optimal integration of pharmacy’s requirements and contributions into the electronic health record.”
Among the collaborative’s founding members: the American Pharmacists Association, the National Community Pharmacists Association, Academy of Managed Care Pharmacy, Accreditation Council for Pharmacy Education, American Association of Colleges of Pharmacy, American College of Clinical Pharmacy, American Society of Consultant Pharmacists, American Society of Health-System Pharmacists and National Alliance of State Pharmacy Associations.
“In order for patients to receive optimal care, pharmacists need to have the ability to access and contribute to relevant, patient-specific information from the EHR. The work of the collaborative will focus on achieving this goal,” said Tom Menighan, EVP and CEO of APhA, who will chair the working group.
Serving as its director will be Rachelle “Shelly” Spiro, a pharmacist and long-term care specialist who heads Spiro Consulting. Spiro is active in national pharmacy associations, standards development organizations and is a leader in pharmacy health IT.
Abbott’s multipurpose disinfecting solution for contacts gets FDA OK
ABBOTT PARK, Ill. Abbott has received market clearance from the Food and Drug Administration for RevitaLens Ocutec, a multipurpose disinfecting solution for silicone hydrogel and conventional soft contact lenses.
"This advanced, next-generation solution establishes a new standard of disinfecting technology for contact lens wearers," stated Jim Mazzo, SVP Abbott Medical Optics. "Proper contact lens care, including a rub and rinse regimen using RevitaLens Ocutec, will help patients achieve clean and comfortable lenses while enhancing overall lens-wearing satisfaction."
RevitaLens Ocutec multipurpose disinfecting solution was developed in cooperation with silicone hydrogel, microbiology and chemistry experts and with input from more than 600 eye care professionals.
It is estimated that there are 125 million contact lens wearers worldwide. Multipurpose solutions represent the majority of systems used for the care of soft contact lenses. These are comprised of a single solution for the rinsing, cleaning, disinfection and storage of lenses, and typically are composed of a preservative, buffer system and other agents to aid in lens cleaning and comfort.
Key characteristics of RevitaLens Ocutec multipurpose disinfecting solution include:
- High micro-organism kill rates;
- Removes proteins from the lens surface;
- Effectively kills acanthamoeba and fusarium;
- Reduces corneal staining; and
- Minimizes the risk of eye complications.
Abbott plans to begin retail shipment of RevitaLens Ocutec multipurpose disinfecting solution in the United States in October. The product also has CE Mark approval in Europe.