The US Food and Drug Administration has issued a Complete Response Letter regarding US-based pharmaceutical company Merck's (NYSE: MRK) Supplemental New Drug Applications for Januvia (sitagliptin), Janumet (sitagliptin and metformin HCl
) and Janumet XR (sitagliptin and metformin HCl
extended-release), the company said.
Table-4: Recovery of Metformin HCl
from Spiked Serum and Urine.
Sun began recalling the bottles of metformin HCL
extended- release tables in the US on January 28 after it received a customer complaint that one of the bottles contained tablets of gabapentin, a medicine used to treat epilepsy, according to a statement on the FDA website.
TABLE 1: It contains the composition and formulation parameters of metformin HCl
loaded microspheres using mucilage of D.
Design and evaluation of a gastroretentive drug delivery system for metformin HCl
using synthetic and semi-synthetic polymers
In Q113, ANMAT approved once daily Aubagio (teriflunomide) 14mg as a new treatment indicated for patients with relapsing forms of multiple sclerosis (MS); abatacept for the treatment of adults with moderate-to-severe rheumatoid arthritis and Kombiglyze XR (saxagliptin + metformin HCl
extendedrelease) for the treatment of type 2 diabetes.
Formulation and optimization of sustained release matrix tablet of metformin HCl
using response surface methodology .
Glumetza(TM) is a once-daily extended-release formulation of metformin HCl
and is intended to control diabetes mellitus - a condition characterized by high levels of blood glucose resulting from defects in insulin secretion, insulin activity or both.
Food and Drug Administration (FDA) has issued a Complete Response Letter regarding Mercks Supplemental New Drug Applications for JANUVIA (sitagliptin), JANUMET (sitagliptin and metformin HCl
) and JANUMET XR (sitagliptin and metformin HCl
In 2016 Epic has launched oxycodone HCl tabs, demeclocycline HCl tabs, metformin HCl
tabs and, most recently, benzphetamine HCl tabs.
This agreement will see the company sell its global diabetes business that was part of its collaboration with AstraZeneca, which includes Onglyza (saxagliptin), Kombiglyze XR/Komboglyze (saxagliptin and metformin HCl
extended release), dapagliflozin (marketed as Forxiga outside the US), Byetta (exenatide), Bydureon (exenatide extended release for injectable suspension), Symlin (pramlintide acetate) and metreleptin.
Accurately weighed amount of metformin HCl
std about 25 mg was dissolved in mobile phase as a diluent and make up to 50 ml and 5 ml of its volume to 100 ml with diluent the concentration prepared approximately 25 ppm.