Overview
Title
Fosun Pharma USA Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction
Agencies
ELI5 AI
The FDA accidentally said some medicine approvals were taken away, but actually, they're not. The companies that make these medicines asked not to lose their approval, and the FDA fixed the mistake and said, "Oops, you're still good to go!"
Summary AI
The Food and Drug Administration (FDA) announced a correction to a previous notice regarding the withdrawal of approval for 23 abbreviated new drug applications (ANDAs). These applications, held by companies like Fosun Pharma USA Inc., Baxter Healthcare Corp., Celltrion USA, and i3 Pharmaceuticals, were initially set to be withdrawn by August 28, 2024. However, because these companies asked in time not to have their ANDAs withdrawn, the approvals remain valid. This notice clarifies the error and ensures the continued approval of these drug applications.
Abstract
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on July 29, 2024. The document announced the withdrawal of approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of August 28, 2024. The document indicated that FDA was withdrawing approval of the ANDAs 073462 for tolmetin sodium capsules, equivalent to (EQ) 400 milligrams (mg) base; 073588 for tolmetin sodium tablets, EQ 200 mg base; 074002 for tolmetin sodium tablets, EQ 600 mg base; 077040 for citalopram hydrobromide tablets, EQ 10 mg base, EQ 20 mg base; EQ 40 mg base; 085787 for trifluoperazine hydrochloride (HCl) concentrate, EQ 10 mg base/milliliters (mL); 086808 for cyproheptadine HCl tablets, 4 mg; 087774 for phenylbutazone capsules, 100 mg; and 088602 for pseudoephedrine HCl; triprolidine HCl tablets, 60 mg/2.5.mg, held by Fosun Pharma USA Inc., 104 Carnegie Center, Suite 204, Princeton, NJ 08540. Additionally, ANDAS 075631 for ketorolac tromethamine injectable, 15 mg/mL and 30 mg/mL; 076427 for milrinone lactate injectable, EQ 1 mg base/mL; 076791 for haloperidol lactate injectable, EQ 5 mg base/mL; 076828 haloperidol lactate injectable, EQ 5 mg base/ mL; 077947 for fluconazole injectable, 200 mg/100 mL (2 mg/mL) and 400 mg/200 mL (2 mg/mL); 078197 for granisetron HCl injectable, EQ 0.1 mg base/mL (EQ 0.1 mg base/mL); 091436 for levofloxacin injectable, EQ 500 mg/20 mL (EQ 25 mg/mL); 207101 for sumatriptan succinate injectable, EQ 6 mg base/0.5 mL (EQ12 mg base/mL); and 215065 for methocarbamol solution, 1gram/10 mL (100 mg/mL), held by Baxter Healthcare Corp., One Baxter Parkway, Deerfield, IL 60015; and the ANDAs 090367 for levofloxacin tablets, 250 mg, 500 mg, 750 mg; and 211959 for clobazam tablets, 10 mg and 20 mg, held by Celltrion USA, Inc., U.S. Agent for Celltrion, Inc., One Evertrust Plaza, Suite 1207, Jersey City, NJ 07302; and the ANDA 212053 for chlorzoxazone tablet, 375 mg and 750 mg, held by i3 Pharmaceuticals LLC, 200 Park Ave., Warminster, PA 18974. Before FDA withdrew the approval of these ANDAs, Fosun Pharma USA Inc.; Baxter Healthcare Corp.; Celltrion USA, Inc., U.S. Agent for Celltrion, Inc.; and i3 Pharmaceuticals LLC, 200 Park Ave., Warminster, PA 18974, informed FDA that they did not want the approval of the ANDAs withdrawn. Because Fosun Pharma USA Inc.; Baxter Healthcare Corp.; Celltrion USA, Inc., U.S. Agent for Celltrion, Inc.; and i3 Pharmaceuticals, LLC, timely requested that approval of their respective ANDAs not be withdrawn, the approvals are still in effect. This notice corrects these errors.
Keywords AI
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AnalysisAI
The recent notice from the Food and Drug Administration (FDA) is a correction to a previously published document concerning the withdrawal of approval for 23 abbreviated new drug applications (ANDAs). Initially, it was announced that the approval for these drug applications, held by companies such as Fosun Pharma USA Inc., Baxter Healthcare Corp., Celltrion USA, and i3 Pharmaceuticals, would be withdrawn by August 28, 2024. However, these companies successfully requested that their approvals not be withdrawn, resulting in a correction that maintains the validity of these ANDAs.
Significant Issues and Concerns
One issue evident in the document is its complex nature, with numerous pharmaceutical terms and specific ANDA numbers. Such information can be challenging for the general public to comprehend without specialized knowledge in the pharmaceutical sector. This complexity can lead to confusion regarding which drug applications are affected and what the implications might be.
Moreover, the original notice did not provide clear reasoning as to why the FDA decided to withdraw the ANDAs or why the decision was subsequently reversed. For stakeholders and the general public, understanding the rationale behind such major regulatory actions is crucial for transparency and trust.
Additionally, the document relies heavily on the reader's familiarity with Federal Register conventions. This approach assumes a level of understanding that may not be shared by all, potentially leaving some readers uncertain about the significance and proceedings of the notice and its correction.
Public Impact
For the general public, the maintenance of these drug application approvals means continued access to a variety of pharmaceuticals. The document does not specify which drugs were impacted by the correction, but since these are likely to include common prescriptions or critical medications, ensuring their availability remains unbroken is beneficial to public health.
Impact on Specific Stakeholders
For the companies involved—Fosun Pharma USA Inc., Baxter Healthcare Corp., Celltrion USA, and i3 Pharmaceuticals—this correction is crucial. It allows them to continue manufacturing and selling these drugs without the interruption that a withdrawal of approval might have caused.
On the negative side, the lack of clarity and accessibility of the document could cause confusion and concern among stakeholders, including healthcare providers and patients, about the status of the medications. Such confusion could inadvertently impact trust in the drug approval process and the companies involved.
Overall, while the document preserves the necessary drug approvals, its presentation highlights challenges concerning complexity and communication that need to be addressed to ensure that such regulatory announcements can be effectively understood by a wider audience.
Issues
• The document contains complex pharmaceutical terms and ANDA numbers that may be difficult for the general public to understand without specialized knowledge.
• The correction notice does not clearly explain why the original decision to withdraw the ANDAs was made or why the withdrawal decision was apparently reversed.
• The document assumes familiarity with the Federal Register format and practices, which may not be accessible to all readers.
• Contact information is provided for further queries, but no specific guidance is offered on how stakeholders are to proceed following the notice and its correction.
• The correction involves multiple applicants and a significant number of ANDAs, making it challenging for an individual reader to track or verify each specific correction without additional resources or context.