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Regulatory Affairs

US FTC approves Teva’s $40.5bn deal for Allergan’s generics business By PBR Staff Writer
The US Federal Trade Commission (FTC) has approved Teva Pharmaceutical Industries’ proposed $40.5bn acquisition of Allergan’s generics business.
Regulatory Affairs > News
FDA lifts clinical hold on CGF166 GenVec, a clinical-stage gene delivery company, was notified by its collaborator, Novartis, that the Food and Drug Administration (FDA) has lifted the clinical hold on the Phase 1/2 clinical trial of CGF166 in patients with severe to profound hearing loss.
Regulatory Affairs > News FDA raises concerns over manufacturing practice of Valeant’s new ophthalmic solution By PBR Staff Writer
The US Food and Drug Administration has raised concerns over manufacturing practice of Valeant Pharmaceuticals International’s new eye drop.
Regulatory Affairs > News
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European CHMP recommends Shire’s Onivyde to treat metastatic adenocarcinoma
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for Shire’s Onivyde (irinotecan pegylated liposomal formulation) to treat metastatic adenocarcinoma.
Regulatory Affairs > News
European CHMP adopts positive opinion on Gilead’s Type II variation application for Truvada
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Gilead Sciences' Type II variation application for Truvada for reducing the risk of sexually acquired HIV.
Regulatory Affairs > News
FDA approves Relistor tablets to treat OIC in chronic non-cancer pain adults
By PBR Staff Writer
The US Food and Drug Administration has approved Relistor (methylnaltrexone bromide) tablets to treat opioid-induced constipation (OIC) in adults with chronic non-cancer pain.
Regulatory Affairs > News
FDA approves expanded label for NAMZARIC to treat moderate to severe Alzheimer's disease
Allergan and Adamas Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved a new, expanded label for NAMZARIC (memantine and donepezil hydrochlorides) extended-release, a once-daily, fixed-dose combination of memantine hydrochloride (a NMDA receptor antagonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor, AChEI).
Regulatory Affairs > News
European Commission approves AstraZeneca’s Qtern to treat type 2 diabetes
By PBR Staff Writer
AstraZeneca has secured approval from the European Commission (EC) for Qtern tablets to treat type 2 diabetes.
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Perrigo wins FDA approval fo romeprazole and sodium bicarbonate capsules, 20mg/1100mg
The U.S. Food and Drug Administration has approved Perrigo's ANDA for omeprazole and sodium bicarbonate capsules, 20mg/1100mg.
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Fera Pharmaceuticals and Oakwood Labs announce ANDA approval of Levothyroxine Sodium for Injection
Fera Pharmaceuticals and Oakwood Laboratories announced that on June 29, 2016, the FDA approved their ANDA for 100 and 500 mcg Levothyroxine Sodium for Injection.
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Celgene’s Revlimid approved in Europe for relapsed or refractory mantle cell lymphoma
By PBR Staff Writer
Celgene has secured approval from the European Commission for Revlimid (lenalidomide) to treat patients with relapsed/refractory mantle cell lymphoma (MCL).
Regulatory Affairs > News
Eisai and Arena Pharmaceuticals secure regulatory approval of VENESPRI in Mexico
Eisai and Arena Pharmaceuticals announced that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) has granted regulatory approval of the chronic weight management agent VENESPRI (lorcaserin HCl: U.S. brand name: BELVIQ) for commercialization by Eisai Laboratorios, S. de R.L. de C.V. (Eisai Mexico) in Mexico.
Regulatory Affairs > News
Shire’s Xiidra secures FDA approval for dry eye disease
By PBR Staff Writer
Shire has secured approval from the US Food and Drug Administration (FDA) for its Xiidra (lifitegrast ophthalmic solution) to treat signs and symptoms of dry eye disease.
Regulatory Affairs > News
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