FDA advises health care professionals and patients about insulin pen packaging and dispensing | FDA

FDA advises health care professionals and patients about insulin pen packaging and dispensing | 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

October 13, 2020

• CDER Statement: FDA advises health care professionals and patients about insulin pen packaging and dispensing
• Drugs@FDA Data Files (updated)
• Office of Generic Drugs: Offices and Divisions (Updated)
• Upcoming Webcast: Office of New Drug (OND) Research: Seeking Collaborators, Funding Opportunities Available
• Upcoming Webcast: Bridging the Gap – Promoting Safe and Effective Prescription Drug Use in Geriatric Patients

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.

October 9, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Lamictal NDA #020241	Lamotrigine	Tablet; Oral	SUPPL-58	Glaxosmithkline Llc	Labeling	Approved
Lamictal Cd NDA #020764	Lamotrigine	Tablet, Chewable; Oral	SUPPL-51	Glaxosmithkline Llc	Labeling	Approved
Tindamax NDA #021618	Tinidazole	Tablet; Oral	SUPPL-7	Mission Pharma	Labeling	Approved
Lamictal Xr NDA #022115	Lamotrigine	Tablet, Extended Release; Oral	SUPPL-24	Glaxosmithkline Llc	Labeling	Approved
Lamictal Odt NDA #022251	Lamotrigine	Tablet, Orally Disintegrating; Oral	SUPPL-22	Glaxosmithkline Llc	Labeling	Approved
Unasyn NDA #050608	Ampicillin Sodium; Sulbactam Sodium	Injectable; Injection	SUPPL-47	Pfizer	Labeling	Approved
Avastin BLA #125085	Bevacizumab	Vial; Intravenous	SUPPL-336	Genentech	Labeling	Approved
Levonorgestrel and Ethinyl Estradiol ANDA #207033	Ethinyl Estradiol; Levonorgestrel	Tablet; Oral-28	ORIG-1	Accord Hlthcare		Approved
Baclofen ANDA #212378	Baclofen	Tablet; Oral	ORIG-1	Innogenix		Approved
Ultomiris BLA #761108	Ravulizumab-Cwvz	Injectable; Injection	SUPPL-5	Alexion Pharm	Efficacy	Approved

October 8, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Montelukast Sodium ANDA #200405	Montelukast Sodium	Tablet, Chewable; Oral	SUPPL-14	Lannett Co Inc	Labeling	Approved
Montelukast Sodium ANDA #200405	Montelukast Sodium	Tablet, Chewable; Oral	SUPPL-10	Lannett Co Inc	Labeling	Approved
Montelukast Sodium ANDA #200405	Montelukast Sodium	Tablet, Chewable; Oral	SUPPL-12	Lannett Co Inc	Labeling	Approved
Montelukast Sodium ANDA #200405	Montelukast Sodium	Tablet, Chewable; Oral	SUPPL-14	Lannett Co Inc	Labeling	Approved
Montelukast Sodium ANDA #200405	Montelukast Sodium	Tablet, Chewable; Oral	SUPPL-10	Lannett Co Inc	Labeling	Approved
Montelukast Sodium ANDA #200405	Montelukast Sodium	Tablet, Chewable; Oral	SUPPL-12	Lannett Co Inc	Labeling	Approved
Montelukast Sodium ANDA #201522	Montelukast Sodium	Tablet; Oral	SUPPL-14	Lannett Co Inc	Labeling	Approved
Montelukast Sodium ANDA #201522	Montelukast Sodium	Tablet; Oral	SUPPL-10	Lannett Co Inc	Labeling	Approved
Montelukast Sodium ANDA #201522	Montelukast Sodium	Tablet; Oral	SUPPL-12	Lannett Co Inc	Labeling	Approved
Montelukast Sodium ANDA #201522	Montelukast Sodium	Tablet; Oral	SUPPL-14	Lannett Co Inc	Labeling	Approved
Montelukast Sodium ANDA #201522	Montelukast Sodium	Tablet; Oral	SUPPL-10	Lannett Co Inc	Labeling	Approved
Montelukast Sodium ANDA #201522	Montelukast Sodium	Tablet; Oral	SUPPL-12	Lannett Co Inc	Labeling	Approved
Lansoprazole ANDA #207157	Lansoprazole	Capsule, Delayed Rel Pellets; Oral	SUPPL-1	Lannett Co Inc	Labeling	Approved
Lansoprazole ANDA #207157	Lansoprazole	Capsule, Delayed Rel Pellets; Oral	SUPPL-1	Lannett Co Inc	Labeling	Approved
Lansoprazole ANDA #207157	Lansoprazole	Capsule, Delayed Rel Pellets; Oral	SUPPL-2	Lannett Co Inc	Labeling	Approved
Lansoprazole ANDA #207157	Lansoprazole	Capsule, Delayed Rel Pellets; Oral	SUPPL-1	Lannett Co Inc	Labeling	Approved
Lansoprazole ANDA #207157	Lansoprazole	Capsule, Delayed Rel Pellets; Oral	SUPPL-2	Lannett Co Inc	Labeling	Approved
Rubraca NDA #209115	Rucaparib Camsylate	Tablet; Oral	SUPPL-8	Clovis Oncology Inc	Efficacy	Approved
Xenleta NDA #211672	Lefamulin Acetate	Tablet; Oral	SUPPL-1	Nabriva	Labeling	Approved
Xenleta NDA #211673	Lefamulin Acetate	Solution; Intravenous	SUPPL-1	Nabriva	Labeling	Approved
Albuterol Sulfate ANDA #213524	Albuterol Sulfate	Tablet; Oral	ORIG-1	Eywa		Approved
Promethazine Hydrochloride and Codeine Phosphate ANDA #214238	Codeine Phosphate; Promethazine Hydrochloride	Syrup; Oral	ORIG-1	Quagen		Approved