Orphenadrine Recalled Due to Possible Nitrosamine Impurity

Orphenadrine Recalled Due to Possible Nitrosamine Impurity

[ad_1] Recent tests of 13 lots of the skeletal muscle relaxant Orphenadrine Citrate 100 mg Extended Release (ER) found unacceptably high levels of a nitrosamine impurity in the tablets, leading manufacturer Sandoz (Princeton, New Jersey) to announce a voluntary recall of the lots on March 21. The nitrosamine impurity detected (N-methyl-N-nitroso-2-[(2-methylphenyl)phenylmethoxy]ethanamine [NMOA or Nitroso-Orphenadrine]) may…

Does the US Have Enough Abortion Providers?

Does the US Have Enough Abortion Providers?

[ad_1] A small, and likely decreasing, number of healthcare providers in the United States perform abortions, and there is a risk that the count will be shrinking in the face of legislative attacks on the service, researchers have found. Until now, producing an accurate count of abortion service providers in the United States has been…

Does the FDA’s Prescribing Label Fall Short?

Does the FDA’s Prescribing Label Fall Short?

[ad_1] As the controversial Alzheimer’s disease (AD) drug aducanumab (Aduhelm) begins its integration into clinical practice, some physicians are concerned the drug’s prescribing label does not include adequate brain imaging recommendations to detect amyloid-related imaging abnormalities (ARIA). Specifically, the drug’s label calls for three MRI brain scans before, and during, the titration period. The problem…