Generics-maker Lannett has passed FDA inspections at two facilities. The company says the regulator had no Form 483 observations at its Philadelphia plant and two minor observations at the Wyoming facility of subsidiary Cody Laboratories.
Cody, a manufacturer of pain management drugs, became ensnared in an ongoing FDA effort to require makers of unapproved drugs to gain formal agency approval. Cody and Lannett argue that the drug in question--morphine sulfate oral solution 20 mg/ml--is grandfathered because of its use prior to the establishment of the FDA and therefore requires no approval.
The company had been making and supplying the drug--as had other manufacturers--for some years prior to the action. One of the other drugmakers is Roxane Laboratories, which gained FDA approval for its version in January. That approval triggered the FDA action against Cody, which announced the following month its plans to file an NDA.
- here's the Lannett announcement