Glenmark Generics Inc and partner InvaGen has got the Abbreviated New Drug Application (ANDA) approval from the FDA for Fosinopril Sodium and Hydrochlorothiazide tablet to be used for the treatment of hypertension. Fosinopril Sodium and Hydrochlorothiazide(HCTZ) tablets are available in both 10mg/12.5mg and 20mg/12.5mg strengths. While Glenmark would exclusively market and distribute the product in the US, InvaGen would manufacture and supply the drug.

The FDA has asked the makers of Singulair, Accolate, Zyflo and Zyflo CR drugs to include the precaution regarding the reported changes in behavior and mood on their label. All these drugs are used to treat asthma and are leukotriene inhibitors, which affect the leukotriene pathway involved in the body’s response to inflammatory stimuli.

The FDA has proposed to allow drug and medical-device manufacturers to promote the unapproved use of their products through “truthful and non-misleading” medical journal articles. The FDA has issued preliminary guidelines for drug companies to distribute medical journal articles to doctors on the “off-label” uses of their FDA-approved drugs. While companies are not allowed to market drugs for off-label uses, doctors are free to prescribe them for unapproved therapies.

The Food and Drug Administration (FDA) is on the erring side when it comes to ensuring that medium- and high-risk medical devices and food supplies are safe for Americans, according to the Government Accountability Office (GAO). Government investigators found that U.S. manufacturing sites of high-risk medical devices are inspected only once every three years, instead of every two years as stipulated by the law, while overseas sites are inspected every six years.

According to the GAO report:

“Efficient use of resources is particularly important at FDA because we found that its food safety workload has increased in the past decade, while its food safety staff and funding have not kept pace.”

According to this story from the LA Downtown News Online, regulatory professionals are a hot commodity with the potential to become some of the top leaders at the major drug and medical device companies. USC School of Pharmacy is working to train this new group of medical pros through its regulatory science department. Money graph:

“With drug and medical device companies developing products at record levels, there is an urgent need for regulatory professionals who can carefully navigate the science, research and ethical issues confronting these companies.”