While most drugs from India are generics, sometimes Indian products are used by Big Pharma for their top brands, like AstraZeneca's Nexium.
When Baxter International issued product recalls in December and January, it said there had been no reports of adverse events. But Baxter couldn't make that claim Wednesday when the company recalled a single lot of a dialysis product in which mold was found.
The FDA placed an import ban on products from Ranbaxy Laboratories' active pharmaceutical plant in Toansa, India, in January, calling into question its drug analysis and sanitation. But there are other problems at the plant, like worker safety, that the FDA does not address and which get little attention from Indian authorities.
Baxter International, which has had ongoing contamination issues with some of its intravenous products, is now recalling one lot of a peritoneal product used on dialysis patients. It says the lot is contaminated with mold. The announcement, also sent out by the FDA, says there have been adverse reactions reported.
The FDA has held off approval of a new Eli Lilly diabetes drug until partner Boehringer Ingelheim fixes problems at a plant that last year was slapped with a warning letter.
Eli Lilly is staring down the barrel of its Evista patent expiration. And Tuesday, Teva Pharmaceutical Industries won FDA approval to load the bullet. The company's generic version of Lilly's breast cancer and osteoporosis drug got the green light, and Teva says it will hit the U.S. market within a month.
The FDA has rejected one of Eli Lilly's top drug prospects partnered with Boehringer Ingelheim, saying that its SGLT2 drug empagliflozin could not be approved for marketing before Boehringer fixed "deficiencies" at one of its manufacturing facilities.
Amarin's lawyers were just in court last week suing the FDA for limiting the exclusivity it granted the drugmaker's fish oil pill Vascepa. But the Irish drugmaker hustled them back to court Tuesday, this time to sue AzstraZeneca, which is awaiting FDA approval on its own product for treating super-high cholesterol.
The FDA slapped GE Healthcare with a Class I recall--its most serious designation--for its infant resuscitation devices after the company found that malfunctions in the product could cause death.
Hospitals say the FDA and drugmakers should loop in hospitals and group purchasing organizations to attack drug shortages the way police would attack a hostage situation.