Another month for FDA reviewers mostly on stay-at-home work due to the COVID-19 pandemic, and with the states beginning to open slowly, the Office of Generic Drugs (OGD) is chugging right along regarding its approval pace. OGD’s unofficial full approval actions for May of 63 is tied for second place among FY 2020 months thus […]
How many times have you had a question about the listings in the Orange Book (OB) but were not sure who to ask? Well, a lot of people have obviously stood in your shoes, as this draft guidance titled Orange Book Questions and Answers Guidance for Industry (here) publishes a great Q&A from those who […]
Today, in the Federal Register pre-publication notice (here), “the Food and Drug Administration (FDA or Agency) is announcing the availability of draft recommendations for new permitted daily exposures (PDEs) for the residual solvents 2-methyltetrahydrofuran (2-MTHF), cyclopentyl methyl ether (CPME), and tert-butyl alcohol (TBA).” The recommendations are based on the testing parameters established for developing permitted […]
Sports fans, are you deprived of watching real time live sporting events? The German teams have started up in the Bundesliga again. But I have a better idea! How about watching the race to approvals that the Office of Generic Drugs is running? Posting their approval action for April today shows that they are running […]
In a move that has me puzzled, the Government’s award of the contract to a company that does not appear on the FDA’s list of DMF holders, and is not found as a holder of any approved ANDA or NDA in the FDA’s Orange Book seems a bit strange. According to a FOX news story […]
The Office of Generic Drugs updated its March 2020 statistics today (here) with few surprises. As they say on American Idol, when giving the results, “dim the lights and here we go.” The OGD again refused to receive only three ANDAs in March and all three were for standard review ANDAs. There were sixty-three ANDAs […]
We all know that the most expensive prescription is the one the patient does not take. Certainly, there are several factors that impact the decision for a patient to fill a prescription. Failure to comply with medication directions can also impact the health of the patient. These failures to comply can lead to more expensive […]
Looking over the daily COVID-19 updates from the FDA (here), I noticed that the OGD had approved “two generic drugs indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation: succinylcholine chloride injection USP 200 mg/10 mL and cisatracurium besylate injection USP 20 mg/10 mL.” Glad to see that […]
The FDA has added a Black Box warning to the popular drug montelukast (brand name Singulair). A black box warning is one of FDA’s most significant label warnings, and in this case, there are recommendations to potentially change therapeutic decisions based on the severity of the diseases and the potential risk benefit The new warning […]
Clearly, the COVID-19 pandemic has had an impact on clinical studies during drug development, and that includes in vivo bioequivalence studies. The FDA has reacted to the potential issues it sees by issuing a statement entitled Bioequivalence Studies for Submission in ANDAs during the COVID-19 Pandemic (here). In discussing the types of challenges that may […]
