FDA issued a revised bioequivalence recommendation for Lamotrigine ER Tablets calling on the firms to perform fasting and fed bioequivalence studies on the 200 mg tablet and a fasting study on the 50 mg. Neither of these products are the highest or lowest strength in the product strength range of 25 mg to 300 mg […]
When most people hear of Amazon.com, they think of one of the largest online marketplaces for consumer products. What people may not realize is that Amazon is also one of the largest providers for computer power for cloud computing through their subsidiary Amazon Web Services (AWS). Running applications in the cloud is a relatively new […]
While 26-30 Inches of snow fell in the Washington DC corridor, the brunt of the storm has hit the FDA with offices being closed today while the dig out continues. For those of you who had GDUFA, PDUFA goal dates, or TADs scheduled for today, you may have to wait a day or two more […]
On Friday January 22, CDER issued its yearly document outlining what Guidance documents it hopes to issue in 2016. This yearly wish list is always a highlight of the beginning of every calendar year. The document identifies either new guidance documents FDA hopes to release, as well as those it plans to revise. This year […]
According to a recent article in Medscape Medical News (here), the use of compounded hormone therapy to treat symptoms of menopause is a big business and accounts for a significant percentage of some compounding pharmacies income. The article provides an estimate of $1.3 -1.6 billion annually. With the flurry of FDA enforcement actions on pharmacy […]
As previously reported (here), Dr. Reddy’s generic of Nexium was too close to that of the innovator’s “Purple Pill”. Apparently, the firm has changed the color of its capsule and reintroduced the product. But, this does reinforce that fact that generic companies, despite the Office of Generic Drugs’ (OGD) input, desire to have the generics look more like their brand name counterparts.
The FDA has updated its pediatric exclusivity page (here); a search of the document reveals 9 different products received pediatric exclusivity during 2015.The number of awards of pediatric exclusivity in 2015 are substantially higher than the numbers from 2013 or 2014, when 6 awards were made in each of those years. What will 2016 bring?
OGD partially updated its Generic Drugs Activity Report for FY 2016 this morning and it must have found a few more receipts.
FDA recently released a revised draft Guidance outlining its new thinking on the bioequivalence requirements for paliperidone palmitate, representing still another BE guidance revision for a long-acting product, but this time for a long-acting parenteral suspension of this product for schizophrenia. The original draft BE Guidance document for this injectable suspension was issued in August 2011.
December, the last month of the calendar year, may (we hope) represent the new normal in the approval of generic drugs. But there may also be signs of concern regarding submissions on the horizon. The Office of Generic Drugs (OGD) had a modern day record in December with 79 full approvals and 20 tentative approvals for a total of 99 approval actions for original ANDAs for the month.
