Update on May Approvals and Receipts
Just a quick note about yesterday’s posted figures, OGD updated the figures as follows:
Approvals 47
Just a quick note about yesterday’s posted figures, OGD updated the figures as follows:
Approvals 47
In a Federal Register notice today (here), FDA announced its finding that Ondansetron Hydrochloride Injection USP, in plastic, ready-to-use containers containing 32mg/50mL was removed from the market and withdrawn for safety reasons.
In a series of FDA Safety Alerts, Recall Notices, and Enforcement Actions over the last couple of years, the Agency has notified consumers of dozens of OTC products that contain undeclared and dangerous drugs.
The Office of Generic Drugs (OGD) had another good (OK) month in terms of approval actions with the approval of 44 ANDAs and tentative approval of 13 for a total of 57 approval actions for the month…..
The Office of Generic Drugs (OGD) had another good (OK) month in terms of approval actions with the approval of 44 ANDAs and tentative approval of 13 for a total of 57 approval actions for the month. The number of receipts totaled 40 – obviously just under the number of full approvals for the month. […]