CDER New: 8/29/2022

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 August 26, 2022 Guidance E11A Pediatric Extrapolation (Draft) Guidance M12 Drug Interaction Studies (Draft) Guidance Q14 Analytical Procedure Development (Draft) Guidance Q2(R2) Validation of Analytical Procedures (Draft) Guidance E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers (Final) FDA Drug Shortages Amphetamine Oral Suspension, Extended Release (Updated - Resolved) Bumetanide Injection (Updated - Currently in Shortage) Cefazolin Injection (Updated - Currently in Shortage) Dextrose 10% Injection (Updated - Currently in Shortage) Dextrose 5% Injection (Updated - Currently in Shortage) Diltiazem Hydrochloride Injection (Updated - Currently in Shortage) Dobutamine Hydrochloride Injection (Updated - Currently in Shortage) Famotidine Injection (Updated - Resolved) Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage) Lipid Injection (Updated - Currently in Shortage) Mannitol Injection (Updated - Currently in Shortage) Midazolam Injection (Updated - Currently in Shortage) Remifentanil Injection (Updated - Currently in Shortage) Sodium Chloride 0.9% Injection Bags (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. August 25, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Differin NDA #021753 Adapalene Gel; Topical SUPPL-11 Galderma Labs Lp Labeling Approved Tolak NDA #022259 Fluorouracil Cream; Topical SUPPL-8 Hill Dermaceuticals Labeling Approved Tolak NDA #022259 Fluorouracil Cream; Topical SUPPL-8 Hill Dermaceuticals Labeling Approved Augmentin '250' NDA #050564 Amoxicillin; Clavulanate Potassium Tablet; Oral SUPPL-59 Us Antibiotics Labeling Approved Augmentin '500' NDA #050564 Amoxicillin; Clavulanate Potassium Tablet; Oral SUPPL-59 Us Antibiotics Labeling Approved Augmentin '125' NDA #050575 Amoxicillin; Clavulanate Potassium For Suspension; Oral SUPPL-48 Us Antibiotics Labeling Approved Augmentin '250' NDA #050575 Amoxicillin; Clavulanate Potassium For Suspension; Oral SUPPL-48 Us Antibiotics Labeling Approved Augmentin '125' NDA #050597 Amoxicillin; Clavulanate Potassium Tablet, Chewable; Oral SUPPL-51 Us Antibiotics Labeling Approved Augmentin '250' NDA #050597 Amoxicillin; Clavulanate Potassium Tablet, Chewable; Oral SUPPL-51 Us Antibiotics Labeling Approved Augmentin '875' NDA #050720 Amoxicillin; Clavulanate Potassium Tablet; Oral SUPPL-33 Us Antibiotics Labeling Approved Augmentin '200' NDA #050725 Amoxicillin; Clavulanate Potassium For Suspension; Oral SUPPL-35 Us Antibiotics Labeling Approved Augmentin '400' NDA #050725 Amoxicillin; Clavulanate Potassium For Suspension; Oral SUPPL-35 Us Antibiotics Labeling Approved Augmentin '200' NDA #050726 Amoxicillin; Clavulanate Potassium Tablet, Chewable; Oral SUPPL-26 Us Antibiotics Labeling Approved Augmentin '400' NDA #050726 Amoxicillin; Clavulanate Potassium Tablet, Chewable; Oral SUPPL-26 Us Antibiotics Labeling Approved Pemazyre NDA #213736 Pemigatinib Tablet; Oral SUPPL-2 Incyte Corp Efficacy Approved August 24, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Differin NDA #022502 Adapalene Lotion; Topical SUPPL-8 Galderma Labs Lp Labeling Approved Myorisan ANDA #076485 Isotretinoin Capsule; Oral SUPPL-30 Douglas Pharms Labeling Approved Divalproex Sodium ANDA #078182 Divalproex Sodium Tablet, Delayed Release; Oral SUPPL-19 Upsher Smith Labs Labeling Approved Divalproex Sodium ANDA #078182 Divalproex Sodium Tablet, Delayed Release; Oral SUPPL-20 Upsher Smith Labs Labeling Approved Divalproex Sodium ANDA #078182 Divalproex Sodium Tablet, Delayed Release; Oral SUPPL-19 Upsher Smith Labs Labeling Approved Divalproex Sodium ANDA #078182 Divalproex Sodium Tablet, Delayed Release; Oral SUPPL-20 Upsher Smith Labs Labeling Approved Divalproex Sodium ANDA #078182 Divalproex Sodium Tablet, Delayed Release; Oral SUPPL-22 Upsher Smith Labs Labeling Approved Divalproex Sodium ANDA #078182 Divalproex Sodium Tablet, Delayed Release; Oral SUPPL-19 Upsher Smith Labs Labeling Approved Clindamycin Palmitate Hydrochloride ANDA #202409 Clindamycin Palmitate Hydrochloride For Solution; Oral SUPPL-2 Aurobindo Pharma Ltd Labeling Approved Clindamycin Palmitate Hydrochloride ANDA #202409 Clindamycin Palmitate Hydrochloride For Solution; Oral SUPPL-3 Aurobindo Pharma Ltd Labeling Approved Clindamycin Palmitate Hydrochloride ANDA #202409 Clindamycin Palmitate Hydrochloride For Solution; Oral SUPPL-4 Aurobindo Pharma Ltd Labeling Approved Clindamycin Palmitate Hydrochloride ANDA #202409 Clindamycin Palmitate Hydrochloride For Solution; Oral SUPPL-7 Aurobindo Pharma Ltd Labeling Approved Clindamycin Palmitate Hydrochloride ANDA #202409 Clindamycin Palmitate Hydrochloride For Solution; Oral SUPPL-11 Aurobindo Pharma Ltd Labeling Approved Clindamycin Palmitate Hydrochloride ANDA #202409 Clindamycin Palmitate Hydrochloride For Solution; Oral SUPPL-12 Aurobindo Pharma Ltd Labeling Approved Naproxen and Esomeprazole Magnesium ANDA #204470 Esomeprazole Magnesium; Naproxen Tablet, Delayed Release; Oral ORIG-1 Actavis Labs Fl Inc   Approved Imbruvica NDA #205552 Ibrutinib Capsule; Oral SUPPL-37 Pharmacyclics Inc Efficacy Approved Imbruvica NDA #205552 Ibrutinib Capsule; Oral SUPPL-38 Pharmacyclics Inc Efficacy Approved Imbruvica NDA #205552 Ibrutinib Capsule; Oral SUPPL-36 Pharmacyclics Inc Efficacy Approved Imbruvica NDA #210563 Ibrutinib Tablet; Oral SUPPL-13 Pharmacyclics Inc Efficacy Approved Imbruvica NDA #210563 Ibrutinib Tablet; Oral SUPPL-14 Pharmacyclics Inc Efficacy Approved Imbruvica NDA #210563 Ibrutinib Tablet; Oral SUPPL-12 Pharmacyclics Inc Efficacy Approved Isotretinoin ANDA #212333 Isotretinoin Capsule; Oral SUPPL-3 Upsher Smith Labs Labeling Approved Isotretinoin ANDA #212333 Isotretinoin Capsule; Oral SUPPL-3 Upsher Smith Labs Labeling Approved Isotretinoin ANDA #213571 Isotretinoin Capsule; Oral SUPPL-3 Upsher Smith Labs Labeling Approved Isotretinoin ANDA #213571 Isotretinoin Capsule; Oral SUPPL-3 Upsher Smith Labs Labeling Approved Wegovy NDA #215256 Semaglutide Solution; Subcutaneous SUPPL-3 Novo Labeling Approved Ramelteon ANDA #215435 Ramelteon Tablet; Oral ORIG-1 Enaltec   Approved Midostaurin ANDA #215834 Midostaurin Capsule; Oral ORIG-1 Lotus Pharm Co Ltd   Tentative Approval Imbruvica NDA #217003 Ibrutinib Capsule; Oral ORIG-1 Pharmacyclics Inc Type 5 - New Formulation or New Manufacturer Approved Imbruvica NDA #217003 Ibrutinib Suspension; Oral ORIG-1 Pharmacyclics Inc Type 5 - New Formulation or New Manufacturer Approved Imbruvica NDA #217003 Ibrutinib Tablet; Oral ORIG-1 Pharmacyclics Inc Type 5 - New Formulation or New Manufacturer Approved Manage Subscriptions  |  Unsubscribe All  |  Help This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA