FDA approves Acton asthma drug
MARLBOROUGH, Mass. – The Food and Drug Administration has approved a drug made by Acton Pharmaceuticals for asthma, the company said Thursday.
The drug maker announced the approval of Aerospan (flunisolide HFA) inhalation aerosol as a maintenance treatment for asthma in patients aged 6 and older. The drug maker plans to launch the drug in early 2013.
Asthma affects more than 24 million Americans, according to the Centers for Disease Control and Prevention, and healthcare market research firm IMS Health estimates the market for inhaled steroids to be worth $8.3 billion.
Mobile MTM developer receives NIH grant
CHICAGO – A company developing mobile medication therapy management technology got a big boost from the federal government.
Leap of Faith Technologies announced that it had received a grant worth more than $1 million from the National Cancer Institute, part of the National Institutes of Health, to develop its eMedonline software-as-service mHealth mobile-health platform for iPhone and Android devices. The company said the platform improves medication adherence, monitors outcomes and provides opportunities for drug surveillance and research data mining, saying the platform had demonstrated medication adherence levels of 98%, along with “significant” improvements in patient self-efficacy in NIH- and industry-funded clinical trials.
The company hopes to use the grant to bring its technology to the marketplace, and an industry partner will match the NIH grant to connect the platform to an electronic health record system.
Leap of Faith founder and chief science officer Barbara Rapchak said, “eMedonline represents the convergence of mobile technology, clinical and behavioral science and validated clinical outcomes in a mHealth platform that facilitates coordinated care and also supports meaningful use.”
Dr. Reddy’s launches antibiotic products
HYDERABAD, India — Drug maker Dr. Reddy’s Labs has launched a generic antibiotic drug, the company said Thursday.
The India-based company announced the launch of amoxicillin tablets, capsules and oral suspension. The tablets are being launched in the 500-mg and 875-mg strengths, while the capsules are in the 250-mg and 500-mg strengths, and the oral suspension is in the 125-mg-, 200-mg-, 250-mg- and 400-mg-per-5-mL strengths.
The drug is a generic version of GlaxoSmithKline’s Amoxil. For the 12-month period ended in June, branded and generic versions of the drug had sales of $22.2 million for the tablets, $67.2 million for the capsules and $89.5 million for the oral suspension, according to IMS Health.