Enforcement Report - Week of August 18, 2021
The bad news for heartburn sufferers, of course, is that Zantac and its ranitidine generics have, perhaps for years, contained a suspected carcinogen without the FDA knowing it. The good news is that the FDA has now declared a handful of branded antacid alternatives and their generics as safe for consumers.
The first analyzes of the National Programme for Drug Quality Check (Proveme) gave satisfactory results for all evaluated drugs. There were seven different active ingredients, with a total of 20 samples in the first month of the program. This is only the first test result with collected products on the market. The program, which was taken over by the agency last August, provides for the analysis of 1,800 samples by 2018.
The objective was to assess the impact of larger than conventional amounts of 14 commonly used excipients on Biopharmaceutics Classification System (BCS) class 3 drug absorption in humans. Cimetidine and acyclovir were used as model class 3 drugs across three separate four-way crossover bioequivalence (BE) studies (n ¼ 24 each) in healthy human volunteers, denoted as study 1A, 1B, and
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today presented positive results from the LATTE-2 study at the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston. Headline results were announced in November 2015.
In a relief for U.S. drug major Merck Sharp and Dohme, the Delhi High Court on Wednesday restrained Indian firm Glenmark Pharmaceuticals from manufacturing and selling its anti-diabetes drugs Zita and Zita-Met.nn“Injunction allowed,” Justice A.K. Pathak said. He added that the U.S. drug major shall be entitled to actual cost of the proceedings.
Attix Pharmaceuticals Recalls Hundreds of APIs From the U.S.