Topic: FDA warning letter
Tris Pharma, which was slapped this year with a warning letter, is recalling three lots of an infants' pain reliever it says could be harmful.
Mylan has expanded its valsartan recall to all lots; a Japanese company is buying a Boehringer Ingelheim API plant, plus more manufacturing news.
Mylan on Tuesday acknowledged that the FDA had issued a warning letter for its troubled Morgantown, West Virginia, manufacturing plant.
The FDA's promo police issued their 7th official reprimand this year—and its third this month—to Vanda Pharmaceutical for webpage infractions.
The latest admonishment from the FDA's promo police is an unusual one. In it, the agency scolds an Eisai sales rep accused of misleading HCPs.
China fines vaccine scandal-hit Changsheng $1.3 billion; Merck and Samsung bail on a Lantus biosim; Taiho grows VC fund to sixfold.
The FDA OPDP slapped a warning letter on Mannkind for failing to mention Afrezza's risks.
The FDA, which banned products from a South Korean sterile manufacturer last spring, has now followed up with a warning letter.
The FDA said it uncovered a second and unexpected cancer-causing impurity in three batches of the blood pressure medicine valsartan that were sold by Torrent Pharmaceuticals.
India’s Sun Pharmaceuticals, which is working to shift its focus to novel and specialty drugs, has won FDA approval of a new treatment for glaucoma.