On January 11, 2018, we went out on a limb prognosticating that the very low numbers of ANDA approvals in January might be linked to a new USP requirement on documentation of elemental impurities that went into effect January 1st (see post here). Since that time, the number of approvals has jumped from 2 to […]
The FDA announced today that they are revising labeling to remove any indication for codeine or hydrocodone-containing cough cold products for use in patient under the age of 18. The FDA Safety Communication (here) states: “We are taking this action after conducting an extensive review and convening a panel of outside experts. Both of these […]
Here it is, 11 days into January 2018, and so far this month (at least at the last check this morning) OGD had approved only two ANDAs. Could it be that they pushed so many out in the first quarter of FY 2018 that there were none left to cross the finish line in early […]
The proverbial title of a 1962 hit song by Petula Clark is something that piqued my curiosity today. And yes, I am that old (I was 13 when that song came out and I loved to play with my pet dinosaur). Anyway, I digress! The reason I bring up “Never on Sunday” is, because, as […]
Well, the first quarter of approval actions for original ANDA and receipts are in the books. We reported late last week that OGD fully approved 78 ANDAs and tentatively approved 19 ANDAs in December – well, we were as close as we ever have been, estimating using numbers derived from various FDA statistical reports… and […]
To reiterate our post of December 27, 2017 (here), please start working on your one time report on the marketing status of your products listed in the Orange Book. The deadline is approaching and FDA even republished its advice to industry (here) again today! Don’t be left without a retort – be sure to submit […]
While OGD has not published the official numbers for December 2017, it appears from the FDA All Approvals list (here) that OGD fully approved 78 ANDAs and tentatively approved 19, for a total of 97 approval actions. While this is slightly lower than the previous two months of FY 2018, it is to be expected, […]
Today, the FDA issued a draft guidance entitled “Good ANDA Submission Practices” (here) along with a new Manual of Policy and Procedure (MaPPs) 5241.3, entitled “Good ANDA Assessment Practices: Manual of Policies and Procedures.” These establish good ANDA assessment practices for the Office of Generic Drugs and the Office of Pharmaceutical Quality to increase their […]
It has been quite a while since FDA totally updated the class labeling guidance for combined hormonal contraceptives (CHC). FDA notes “this newer CHC labeling may be different from the labeling for some older CHC products. The updates to this guidance set forth labeling recommendations that represent newer class labeling that should be included in […]
After the glow of the holiday season, and after the big bowl games and national football championship, you better get the team prepared to file your one-time report of the marketing status of every one of your NDA and ANDA products. FDARA requires every firm to submit the one time written report telling FDA if: […]
