FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class | FDA

FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class | FDA

What's New Related to Drugs

Updated Monday through Friday:

• Drug Firm Annual Registration Status
• Drug Firm Annual Registration Status Download File
• National Drug Code Directory
• NDC Unfinished Drugs Excluded Database File
• NDC Database Excluded Packages and Products
• Wholesale Distributor and Third-Party Logistics Providers Reporting

September 29, 2020

• E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers Guidance for Industry
• FDA Drug Safety Podcast
  • FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class
  • FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)
• FDA Drug Shortages
  • Erlotinib Hydrochloride Tablets (New - Discontinuation)
  • Levetiracetam Immediate-Release Oral Tablets, USP (Updated - Currently in Shortage)
  • Tacrolimus Capsules (Updated - Currently in Shortage)

Recent New and Generic Drug Approvals

This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

September 29, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Lumigan NDA #022184	Bimatoprost	Solution/Drops; Ophthalmic	SUPPL-8	Allergan	Labeling	Approved
Latisse NDA #022369	Bimatoprost	Solution/Drops; Topical	SUPPL-12	Allergan	Labeling	Approved

September 28, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Tekturna Hct NDA #022107	Aliskiren Hemifumarate; Hydrochlorothiazide	Tablet; Oral	SUPPL-34	Noden Pharma	Labeling	Approved
Tekturna Hct NDA #022107	Aliskiren Hemifumarate; Hydrochlorothiazide	Tablet; Oral	SUPPL-34	Noden Pharma	Labeling	Approved
Norepinephrine Bitartrate ANDA #040455	Norepinephrine Bitartrate	Injectable; Injection	SUPPL-22	Teva Pharms Usa	Labeling	Approved
Fluoxetine Hydrochloride ANDA #075049	Fluoxetine Hydrochloride	Capsule; Oral	SUPPL-40	Apnar Pharma Lp	Labeling	Approved
Fluoxetine Hydrochloride ANDA #075049	Fluoxetine Hydrochloride	Capsule; Oral	SUPPL-35	Apnar Pharma Lp	Labeling	Approved
Fluoxetine Hydrochloride ANDA #075049	Fluoxetine Hydrochloride	Capsule; Oral	SUPPL-36	Apnar Pharma Lp	Labeling	Approved
Fluoxetine Hydrochloride ANDA #075049	Fluoxetine Hydrochloride	Capsule; Oral	SUPPL-39	Apnar Pharma Lp	Labeling	Approved
Fluoxetine Hydrochloride ANDA #075049	Fluoxetine Hydrochloride	Capsule; Oral	SUPPL-40	Apnar Pharma Lp	Labeling	Approved
Fluoxetine Hydrochloride ANDA #075049	Fluoxetine Hydrochloride	Capsule; Oral	SUPPL-42	Apnar Pharma Lp	Labeling	Approved
Fluoxetine Hydrochloride ANDA #075049	Fluoxetine Hydrochloride	Capsule; Oral	SUPPL-42	Apnar Pharma Lp	Labeling	Approved
Thiamine Hydrochloride ANDA #080575	Thiamine Hydrochloride	Injectable; Injection	SUPPL-19	West-Ward Pharms Int	Manufacturing (CMC)	Approved
Thiamine Hydrochloride ANDA #080575	Thiamine Hydrochloride	Injectable; Injection	SUPPL-19	West-Ward Pharms Int	Manufacturing (CMC)	Approved
Phenytoin Sodium ANDA #084307	Phenytoin Sodium	Injectable; Injection	SUPPL-48	West-Ward Pharms Int	Labeling	Approved
Phenytoin Sodium ANDA #084307	Phenytoin Sodium	Injectable; Injection	SUPPL-49	West-Ward Pharms Int	Labeling	Approved
Phenytoin Sodium ANDA #084307	Phenytoin Sodium	Injectable; Injection	SUPPL-51	West-Ward Pharms Int	Labeling	Approved
Phenytoin Sodium ANDA #084307	Phenytoin Sodium	Injectable; Injection	SUPPL-54	West-Ward Pharms Int	Labeling	Approved
Phenytoin Sodium ANDA #084307	Phenytoin Sodium	Injectable; Injection	SUPPL-56	West-Ward Pharms Int	Labeling	Approved
Phenytoin Sodium ANDA #084307	Phenytoin Sodium	Injectable; Injection	SUPPL-57	West-Ward Pharms Int	Labeling	Approved
Phenytoin Sodium ANDA #084307	Phenytoin Sodium	Injectable; Injection	SUPPL-60	West-Ward Pharms Int	Labeling	Approved
Docetaxel ANDA #210327	Docetaxel	Injectable; Injection	SUPPL-1	Shilpa Medicare Ltd	Labeling	Approved
Docetaxel ANDA #210327	Docetaxel	Injectable; Injection	SUPPL-2	Shilpa Medicare Ltd	Labeling	Approved
Docetaxel ANDA #210327	Docetaxel	Injectable; Injection	SUPPL-3	Shilpa Medicare Ltd	Labeling	Approved
Bupropion Hydrochloride ANDA #211347	Bupropion Hydrochloride	Tablet, Extended Release; Oral	SUPPL-1	Yichang Humanwell	Labeling	Approved
Bupropion Hydrochloride ANDA #211347	Bupropion Hydrochloride	Tablet, Extended Release; Oral	SUPPL-1	Yichang Humanwell	Labeling	Approved