FDA withdraws approval of 39 new drug applications from Teva, Pfizer and others
The 39 approvals were pulled at the sponsors' request because the products are no longer marketed; the notice gives no safety reason.
The Food and Drug Administration is withdrawing its approval of 39 new drug applications from multiple companies after the sponsors told the agency the products are no longer marketed, according to a Federal Register notice published August 4, 2025 [1].
The notice, filed under Docket No. FDA-2025-N-2422 and running two pages at 90 FR 36440, took effect September 3, 2025 [1]. The applications cover products from companies including Teva Branded Pharmaceutical Products R&D, Pfizer and GE HealthCare [1].
The applications were withdrawn under 21 CFR 314.150(c), a rule that lets a sponsor ask the FDA to pull an approval when a drug is off the market [1]. The notice says the applicants notified the agency in writing that the products were no longer marketed and requested the withdrawal, and that they waived their opportunity for a hearing [1]. The notice also states the withdrawals are "without prejudice to refiling," which means a company could seek approval of the same product again later [1].
Among the products named in the notice are Hexadrol (dexamethasone) in elixir, tablet and injectable forms; Vivactil (protriptyline hydrochloride) 5 mg and 10 mg tablets; Surmontil (trimipramine maleate) capsules; Sinequan (doxepin hydrochloride) capsules and concentrate; Loxitane (loxapine succinate) capsules and tablets; Drytec Technetium Tc99m Generator; Thallous Chloride Tl-201 injection; and M.V.I. Pediatric [1]. The notice's table lists each application number, dosage strength and the company that holds the approval [1]. The listed products span several categories, from decades-old antidepressants and antipsychotics to vitamins and diagnostic imaging agents [1].
The FDA published a correction to the notice on October 3, 2025, in the same docket [1]. Comments on the original notice are no longer being accepted [1].
Why it matters for patients
A withdrawal of approval like this one is an administrative step, not a safety announcement. The notice does not describe any safety problem; it states that the applicants reported the products were no longer marketed and asked the FDA to withdraw the approvals [1].
For someone taking one of these medicines, the practical question is usually whether the product is still available. The notice says the drugs are no longer marketed, but it does not say when each one stopped shipping, how much supply might still be in the distribution chain, or whether a generic version of any listed product exists [1]. It also does not say what patients should do if they still have a supply at home or what alternatives exist [1]. Those details have not been disclosed in the notice.
The withdrawal route matters in another way: it is voluntary on the sponsor's side. Because the withdrawals are without prejudice to refiling, a product on this list is not permanently barred from the US market [1]. The notice likewise does not address whether any of the companies plan to sell the products again [1].
What happens next
The withdrawals took effect September 3, 2025 [1]. The correction published October 3, 2025 is the most recent document in the docket for this action [1]. A company could refile for any of the affected products, since the withdrawals were made without prejudice to refiling [1]. No refiling has been reported. The notice does not give a deadline for any further FDA action, and no further steps have been announced [1].
Sources
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