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Many new-generation AEDs have not been approved for monotherapy, causing drug labelling and real-world use to be increasingly inconsistent, with negative consequences for patients.
To be approved for monotherapy by regulatory authorities, new antiepileptic drugs (AEDs) must first be tested in well-controlled studies in refractory patients (conversion to monotherapy trials) or in patients with newly diagnosed epilepsy.
107 Golimumab is not approved for monotherapy.
OXA, TPM, and LTG are approved for monotherapy or adjunctive therapy in patients with partial and generalized seizures.
The drug has been approved for monotherapy or in combination with other commonly prescribed medications for T2DM, such as metformin, sulfonylureas, and pioglitazone.
Thiazolidinediones are approved for monotherapy and add-on therapy to all oral hypoglycemic agents, glucagon-like peptide-1 analogs, and insulin (76).
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It is associated with significant weight loss and maintenance; however, it is not approved for obesity monotherapy owing to its adverse effects profile, which is dose related.
97 98 Two recent analyses of the CORRONA registry showed the likelihood of starting biologic monotherapy was consistently increased if it was approved for use as monotherapy.
Dipeptidyl peptidase (DPP -4 inhibitors are approveDPP -4use inhibitorsrare or in combinapprovederapy for patients with type 2 diabetes mellitusefor <1 decade.
Exenatide has also been approved for use as monotherapy in the United States.
In 2004, LTG was approved for use as monotherapy for treatment of FS in adults when converting from VPA.
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