More DESI-products cited. Exceptions are noted for unique products.
- Posted by: Ken Phelps
- Published on: September 16, 2008
FDA inspections and citations sometimes take a few weeks to appear on the FDA website. So, “news” is a erlative term here. Nonetheless, activity related to DESI drugs has a keen interest to us because they represent FDA thinking and potential 505(b)(2) projects.
A July 24 Warning Letter was issued by FDA to G & W Laboratories. The letter cited the firm for two major items: cGMP deficiencies and Misbranded and Unapproved New Prescription Drugs. The cGMP deficiencies speak for themselves, though I note that the the FDA showed little patience for the firms response to the 483 observations.
The two DESI era drugs cited are: Chloral Hydrate Rectal Suppositories and Hydrocortisone acetate suppositories. Here it gets interesting. FDA requested immediate discontinuation of chloral hydrate products. But, the FDA asked that the firm notify the FDA before discontinuing the hydrocortisone acetate product. The reason: to avoid ‘any undue burdens on consumers or disruption in the market’. In other words, this is the only producer and the FDA sees some value in the product. FDA asked G & W to contact the FDA to seek FDA approvals.
Seems like hydrocortisone suppository is a good candidate for a 505(b)(2)!