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The facility “kept weed killer, engine antifreeze coolant and dry wall repair products” in the same room where it stored active pharmaceutical ingredients, the FDA said. Read More
The revised REMS, which will go into effect on Nov. 15, mandates that prescribers submit new patient status forms to document their white blood cell counts. Read More
The FDA is requiring the manufacturer suspend enrollment in the trial and has also suspended enrollment in other ongoing Pepaxto clinical trials. Read More
The agency said it will “exercise regulatory flexibility and discretion” to allow Apotex to distribute its Apo-Varenicline tablets in the U.S. Read More
The injectable drug is approved for treatment of certain patients with metastatic ovarian cancer, small-cell lung cancer and recurrent or persistent cervical cancer. Read More
The company said that the pause in distribution of Chantix is out of an abundance of caution and that the drug’s benefits outweigh the very low potential risks posed by nitrosamines. Read More
The FDA issued a warning letter to an over-the-counter (OTC) drugmaker in Gujarat, India for serious violations of current good manufacturing practices. Read More
The FDA issued a warning letter to an over-the-counter (OTC) drugmaker in Gujarat, India for serious violations of current good manufacturing practices. Read More
The FDA noted that Acella has received 43 reports of serious adverse events to date that may be linked to the substandard underactive thyroid drugs. Read More