Conceptos básicos de los Biosimilares para los pacientes | FDA

Conceptos básicos de los Biosimilares para los pacientes | FDA

What's New Related to Drugs

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• Drug Firm Annual Registration Status
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October 7, 2020

• Conceptos básicos de los Biosimilares para los pacientes
• FDA Drug Shortages
  • Leuprolide Acetate Injection (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.

October 7, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Dipentum NDA #019715	Olsalazine Sodium	Capsule; Oral	SUPPL-28	Mylan Speciality Lp	Labeling	Approved

October 6, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Phenytoin Sodium ANDA #040573	Phenytoin Sodium	Injectable; Injection	SUPPL-12	Acella	Labeling	Approved
Doxycycline Hyclate ANDA #209987	Doxycycline Hyclate	Tablet; Oral	ORIG-1	Mylan		Approved
Dimethyl Fumarate ANDA #210226	Dimethyl Fumarate	Capsule, Delayed Release; Oral	ORIG-1	Lupin Atlantis		Approved
Dimethyl Fumarate ANDA #210309	Dimethyl Fumarate	Capsule, Delayed Release; Oral	ORIG-1	Glenmark Pharms Ltd		Approved
Methylphenidate Hydrochloride ANDA #212288	Methylphenidate Hydrochloride	Tablet, Extended Release; Oral	ORIG-1	Alkem Labs Ltd		Approved
Atropine Sulfate ANDA #212461	Atropine Sulfate	Solution; Intravenous	ORIG-1	Intl Medication Sys		Approved
Fosfomycin Tromethamine ANDA #212548	Fosfomycin Tromethamine	For Solution; Oral	ORIG-1	Xiromed		Approved
Ephedrine Sulfate ANDA #212649	Ephedrine Sulfate	Solution; Intravenous	ORIG-1	Dr Reddys Labs Ltd		Approved
Icatibant Acetate ANDA #213054	Icatibant Acetate	Injectable; Subcutaneous	ORIG-1	Dr Reddys		Approved
Diphenoxylate Hydrochloride and Atropine Sulfate ANDA #213335	Atropine Sulfate; Diphenoxylate Hydrochloride	Tablet; Oral	ORIG-1	Specgx Llc		Approved
Dolutegavir, Lamividine and Tenofovir Disoproxil Fumarate NDA #213556		Tablet; Oral	ORIG-1	Shanghai Desana Bio-Pharmaceuticals Co Ltd	Type 4 - New Combination	Tentative Approval
Halobetasol Propionate ANDA #213560	Halobetasol Propionate	Ointment; Topical	ORIG-1	Quagen		Approved
Palynziq BLA #761079	Pegvaliase-Pqpz	Injectable; Injection	SUPPL-5	Biomarin Pharm	Efficacy	Approved
Palynziq BLA #761079	Pegvaliase-Pqpz	Injectable; Injection	SUPPL-6	Biomarin Pharm	Efficacy	Approved
Palynziq BLA #761079	Pegvaliase-Pqpz	Injectable; Injection	SUPPL-7	Biomarin Pharm	Efficacy	Approved