US FDA gets injunction to stop distribution of unapproved drugs

The US Food and Drug Administration has obtained a permanent injunction barring Neilgen Pharmaceuticals of Westminster, Maryland, its parent  company, Advent Pharmaceuticals and two of their officers, Bharat Patel  and Pragna Patel, from manufacturing and distributing any unapproved,  adulterated or misbranded drugs.

Both Neilgen, which does business as Unigen Pharmaceuticals, and Advent  are contract manufacturers and distributors of more than 25 different  unapproved drug products each. The more than 50 uncleared products  primarily include prescription cough and cold agents. The unapproved  drugs manufactured by Unigen and/or Advent include, but are not limited  to: RE All 12 Suspension; BP Allergy Junior Suspension; PE Tann 20mg/CP  Tann 4mg Suspension; BP New Allergy DM Suspension; D-Tann CT Tablets;  B-Vex D Suspension; Histex SR; and Chlorpheniramine Maleate  12mg/Pseudoephedrine HCl 120mg LA Tablets.