CDER New July 5, 2017

What's New on the FDA Drugs Site

July 3, 2017

• Drug Approval Package:  Kevzara (sarilumab) Injection
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

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New and Generic Drug Approvals

June 30, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Activase BLA #103172	Alteplase	Vial; Single-Use	SUPPL-5253	Genentech	Labeling	Approved
Anagrelide Hydrochloride ANDA #209151	Anagrelide Hydrochloride	Capsule; Oral	ORIG-1	Torrent Pharms Ltd		Approved
Bupropion Hydrochloride ANDA #075914	Bupropion Hydrochloride	Tablet, Extended Release; Oral	SUPPL-29	Impax Labs	Labeling	Approved
Bupropion Hydrochloride ANDA #077475	Bupropion Hydrochloride	Tablet, Extended Release; Oral	SUPPL-18	Sandoz Inc	Labeling	Approved
Bupropion Hydrochloride ANDA #077475	Bupropion Hydrochloride	Tablet, Extended Release; Oral	SUPPL-19	Sandoz Inc	Labeling	Approved
Bupropion Hydrochloride ANDA #079094	Bupropion Hydrochloride	Tablet, Extended Release; Oral	SUPPL-24	Actavis Labs Fl Inc	Labeling	Approved
Bupropion Hydrochloride ANDA #079094	Bupropion Hydrochloride	Tablet, Extended Release; Oral	SUPPL-24	Actavis Labs Fl Inc	Labeling	Approved
Bupropion Hydrochloride ANDA #079094	Bupropion Hydrochloride	Tablet, Extended Release; Oral	SUPPL-24	Actavis Labs Fl Inc	Labeling	Approved
Bupropion Hydrochloride ANDA #207224	Bupropion Hydrochloride	Tablet, Extended Release; Oral	ORIG-1	Anbison Lab Co Ltd		Approved
Cathflo Activase BLA #103172	Alteplase	Vial	SUPPL-5253	Genentech	Labeling	Approved
Desyrel NDA #018207	Trazodone Hydrochloride	Tablet; Oral	SUPPL-32	Pragma Pharms Llc	Labeling	Approved
Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate NDA #204119	Efavirenz;Lamivudine;Tenofovir Disoproxil Fumarate	Tablet; Oral	ORIG-1	Hetero Drugs Ltd	Type 4 - New Combination	Tentative Approval
Leflunomide ANDA #077090	Leflunomide	Tablet; Oral	SUPPL-13	Apotex Inc	Labeling	Approved
Olopatadine Hydrochloride ANDA #206087	Olopatadine Hydrochloride	Solution; Ophthalmic	ORIG-1	Cipla Limited		Tentative Approval
Orencia BLA #125118	Abatacept	Injectable; Iv (Infusion)	SUPPL-209	Bristol Myers Squibb	Efficacy	Approved
Pantoprazole Sodium NDA #209463	Pantoprazole Sodium	Injectable; Injection	ORIG-1	Exela Pharma Scs Llc	Type 5 - New Formulation or New Manufacturer	Approved
Phoxillum B22k 4/0 In Plastic Container NDA #207026	Calcium Chloride; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Phosphate	Injectable; Injection	SUPPL-4	Baxter Hlthcare Corp	Labeling	Approved
Phoxillum Bk 4/2.5 In Plastic Container NDA #207026	Calcium Chloride; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Phosphate	Injectable; Injection	SUPPL-4	Baxter Hlthcare Corp	Labeling	Approved
Prismasol B22gk 2/0 In Plastic Container NDA #021703	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Injectable; Injection	SUPPL-18	Baxter Hlthcare Corp	Labeling	Approved
Prismasol B22gk 2/2.5 In Plastic Container NDA #021703	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Injectable; Injection	SUPPL-18	Baxter Hlthcare Corp	Labeling	Approved
Prismasol B22gk 4/0 In Plastic Container NDA #021703	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Injectable; Injection	SUPPL-18	Baxter Hlthcare Corp	Labeling	Approved
Prismasol B22gk 4/2.5 In Plastic Container NDA #021703	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Injectable; Injection	SUPPL-18	Baxter Hlthcare Corp	Labeling	Approved
Prismasol Bgk 0/2.5 In Plastic Container NDA #021703	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Injectable; Injection	SUPPL-18	Baxter Hlthcare Corp	Labeling	Approved
Prismasol Bgk 2/0 In Plastic Container NDA #021703	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Injectable; Injection	SUPPL-18	Baxter Hlthcare Corp	Labeling	Approved
Prismasol Bgk 2/3.5 In Plastic Container NDA #021703	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Injectable; Injection	SUPPL-18	Baxter Hlthcare Corp	Labeling	Approved
Prismasol Bgk 4/0 In Plastic Container NDA #021703	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Injectable; Injection	SUPPL-18	Baxter Hlthcare Corp	Labeling	Approved
Prismasol Bgk 4/0/1.2 In Plastic Container NDA #021703	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Injectable; Injection	SUPPL-18	Baxter Hlthcare Corp	Labeling	Approved
Prismasol Bgk 4/2.5 In Plastic Container NDA #021703	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Injectable; Injection	SUPPL-18	Baxter Hlthcare Corp	Labeling	Approved
Prismasol Bgk 4/3.5 In Plastic Container NDA #021703	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Injectable; Injection	SUPPL-18	Baxter Hlthcare Corp	Labeling	Approved
Prismasol Bk 0/0 In Plastic Container NDA #021703	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Injectable; Injection	SUPPL-18	Baxter Hlthcare Corp	Labeling	Approved
Prismasol Bk 0/0/1.2 In Plastic Container NDA #021703	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Injectable; Injection	SUPPL-18	Baxter Hlthcare Corp	Labeling	Approved
Prismasol Bk 0/3.5 In Plastic Container NDA #021703	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Injectable; Injection	SUPPL-18	Baxter Hlthcare Corp	Labeling	Approved
Prismasol Bk 4/2.5 In Plastic Container NDA #021703	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Injectable; Injection	SUPPL-18	Baxter Hlthcare Corp	Labeling	Approved
Promethazine Hydrochloride ANDA #209177	Promethazine Hydrochloride	Tablet; Oral	ORIG-1	Strides Pharma		Approved
Quetiapine Fumarate ANDA #090120	Quetiapine Fumarate	Tablet; Oral	SUPPL-6	West-Ward Pharms Int	Labeling	Approved
Quetiapine Fumarate ANDA #090120	Quetiapine Fumarate	Tablet; Oral	SUPPL-7	West-Ward Pharms Int	Labeling	Approved
Quetiapine Fumarate ANDA #201109	Quetiapine Fumarate	Tablet; Oral	SUPPL-8	Lupin Ltd	Labeling	Approved
Quetiapine Fumarate ANDA #201109	Quetiapine Fumarate	Tablet; Oral	SUPPL-10	Lupin Ltd	Labeling	Approved
Quetiapine Fumarate ANDA #202152	Quetiapine Fumarate	Tablet; Oral	SUPPL-9	Accord Hlthcare	Labeling	Approved
Quetiapine Fumarate ANDA #202152	Quetiapine Fumarate	Tablet; Oral	SUPPL-10	Accord Hlthcare	Labeling	Approved
Quetiapine Fumarate ANDA #203359	Quetiapine Fumarate	Tablet; Oral	SUPPL-3	Macleods Pharms Ltd	Labeling	Approved
Quetiapine Fumarate ANDA #203359	Quetiapine Fumarate	Tablet; Oral	SUPPL-2	Macleods Pharms Ltd	Labeling	Approved
Quetiapine Fumarate ANDA #203359	Quetiapine Fumarate	Tablet; Oral	SUPPL-3	Macleods Pharms Ltd	Labeling	Approved
Quetiapine Fumarate ANDA #203390	Quetiapine Fumarate	Tablet; Oral	SUPPL-1	Alembic Pharms Ltd	Labeling	Approved
Quetiapine Fumarate ANDA #203390	Quetiapine Fumarate	Tablet; Oral	SUPPL-1	Alembic Pharms Ltd	Labeling	Approved
Quetiapine Fumarate ANDA #203390	Quetiapine Fumarate	Tablet; Oral	SUPPL-2	Alembic Pharms Ltd	Labeling	Approved
Quetiapine Fumarate ANDA #203390	Quetiapine Fumarate	Tablet; Oral	SUPPL-1	Alembic Pharms Ltd	Labeling	Approved
Quetiapine Fumarate ANDA #203390	Quetiapine Fumarate	Tablet; Oral	SUPPL-2	Alembic Pharms Ltd	Labeling	Approved
Zolmitriptan ANDA #206973	Zolmitriptan	Tablet; Oral	ORIG-1	Appco Pharma Llc		Approved

June 29, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Clozapine ANDA #075713	Clozapine	Tablet; Oral	SUPPL-39	Sun Pharm Inds Inc	Labeling	Approved
Clozapine ANDA #075713	Clozapine	Tablet; Oral	SUPPL-38	Sun Pharm Inds Inc	Labeling	Approved
Clozapine ANDA #075713	Clozapine	Tablet; Oral	SUPPL-39	Sun Pharm Inds Inc	Labeling	Approved
Clozapine ANDA #075713	Clozapine	Tablet; Oral	SUPPL-41	Sun Pharm Inds Inc	Labeling	Approved
Lonsurf NDA #207981	Tipiracil Hydrochloride; Trifluridine	Tablet; Oral	SUPPL-6	Taiho Oncology	Labeling	Approved
Norvir NDA #020659	Ritonavir	Solution; Oral	SUPPL-66	Abbvie	Labeling	Approved
Norvir NDA #020659	Ritonavir	Solution; Oral	SUPPL-66	Abbvie	Labeling	Approved
Norvir NDA #020945	Ritonavir	Capsule; Oral	SUPPL-44	Abbvie	Labeling	Approved
Norvir NDA #020945	Ritonavir	Capsule; Oral	SUPPL-44	Abbvie	Labeling	Approved
Norvir NDA #022417	Ritonavir	Tablet; Oral	SUPPL-18	Abbvie	Labeling	Approved
Norvir NDA #022417	Ritonavir	Tablet; Oral	SUPPL-18	Abbvie	Labeling	Approved
Norvir NDA #209512	Ritonavir	Powder; Oral	SUPPL-1	Abbvie Inc	Labeling	Approved
Norvir NDA #209512	Ritonavir	Powder; Oral	SUPPL-1	Abbvie Inc	Labeling	Approved
Otezla NDA #205437	Apremilast	Tablet; Oral	SUPPL-6	Celgene Corp	Labeling	Approved
Oxycodone and Aspirin ANDA #040255	Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate	Tablet; Oral	SUPPL-26	Watson Labs	Labeling	Approved
Tofranil ANDA #087844	Imipramine Hydrochloride	Tablet; Oral	SUPPL-28	Mallinckrodt Inc	Labeling	Approved
Tofranil ANDA #087845	Imipramine Hydrochloride	Tablet; Oral	SUPPL-28	Mallinckrodt Inc	Labeling	Approved
Tofranil ANDA #087846	Imipramine Hydrochloride	Tablet; Oral	SUPPL-29	Mallinckrodt Inc	Labeling	Approved
Tramadol Hydrochloride and Acetaminophen ANDA #077184	Acetaminophen; Tramadol Hydrochloride	Tablet; Oral	SUPPL-13	Sun Pharm Inds Inc	Labeling	Approved
Tramadol Hydrochloride and Acetaminophen ANDA #077184	Acetaminophen; Tramadol Hydrochloride	Tablet; Oral	SUPPL-13	Sun Pharm Inds Inc	Labeling	Approved
Tramadol Hydrochloride and Acetaminophen ANDA #078778	Acetaminophen; Tramadol Hydrochloride	Tablet; Oral	SUPPL-5	Apotex Inc	Labeling	Approved
Triptodur NDA #208956	Triptorelin	Injectable; Suspension	ORIG-1	Arbor Pharms Inc	Type 5 - New Formulation or New Manufacturer	Approved
Vectibix BLA #125147	Panitumumab	Injectable; Iv (Infusion)	SUPPL-207	Amgen	Efficacy	Approved

 

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— Wednesday, July 5, 2017 — Add Comment