We previously intimated (here) that March came in like a lion but might go out like a lamb; however, thanks to a flurry of approval actions in the last four days of the month, it looks like the lion might have stayed in the approval picture for most of the month. The unofficial number of […]
Well, a little late this month, but OGD posted the first wave of its February 2021 metrics. The Agency issued 72 Approval actions and 7 tentative approval actions (we reported 72 and 6 respectively (here -looks like they snuck in a late TA). So, a total of 79 total approval actions in February, which just […]
The FDA has released its most current list of Competitive Generic Therapy (CGT) ANDA approvals (here). CGT-designated products (products for which there is little, if any, generic approvals for NDA products) may be eligible to receive 180-days of market exclusivity from a subsequent ANDA approval for the same strength and product. After any ANDA approval […]
In a podcast, FDA warns that abuse and misuse of the OTC nasal decongestant propylhexedrine can lead to serious harm (here). The warning first came from FDA on March 25, 2021 in the form of a drug safety communication (here). The product marketed as Benzedrex is safe and effective when used in accordance with its […]
March came in like a lion and looks to be going out like a lamb. With seven reporting days left, we counted forty-nine approval actions and four tentative approval actions for the OGD. These numbers are tempered a bit by the fact that (as we have mentioned previously) the OGD reports every action it takes […]
The FDA reviewed five (5) bulk drug substances for inclusion in the bulk APIs that can be used by outsourcing facilities in the compounding of drug products. The five (5) nominated for consideration were: quinacrine HCl, bromfenac sodium, mitomycin–C, nepafenac, and hydroxychloroquine sulfate. Only quinacrine HCL for compounding for oral products for the treatment of […]
There appears to be some concern about Janet Woodcock, MD being selected for the permanent FDA Commissioner job. Not sure why there is so much hype and concern. Most of the pressure being applied from the non-supporters focus on the opioid crisis; however, some critics are being quick to complain about the approval actions that […]
Let me start off by saying you all know that I am a bit bitter about the lack of activity on the 505(j)(2)(C) ANDA suitability petitions. So, in an attempt to soothe my nerves and calm myself down, I looked back to January 1, 2020 to see how many ANDA suitability petitions have been filed […]
In the first 10 business days of February 2021, the Office of Generic Drugs has issued 30 full approval actions and 3 tentative approval actions for total approval actions thus far at 33. There are 9 business days left in this month and, of course, February is only 28 days in total. Even if the […]
The generic community sprung into action with amicus briefs filed by the Association of Accessible Medicines and letters written by various other organizations to challenge the attack on the skinny label. Teva was able to convince the Court of Appeals for the Federal Circuit to rehear its skinny label case. Clearly, Congressional intent and regulatory […]
