Healthcare company Perrigo Company plc (NYSE:PRGO)(TASE:PRGO) reported on Thursday the receipt of final approval from the US Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing Exalgo 32mg extended release
analgesic tablets (hydromorphone HCl).
Indian pharma company Zydus Cadila (NSE: CADILAHC) has received approval from the US Food and Drug Administration (FDA) to market its aspirin and extended release
dipyridamole capsules in the strength of 25mg/200mg, the company confirmed on Wednesday.
Tacrolimus extended release
capsules are a once daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus.
VERxVE is a pivotal trial that compared the frequently prescribed lipid-friendly* antiretroviral ViramuneEeA IR with once daily nevirapine (ViramuneEeA XR.) At week 48, virologic response was 81% (409/505) for nevirapine extended release
formulation compared with 75.9% (384/506) for ViramuneEeA IR.
Importantly, as we will see later, Wyeth's definition of "extended release
formulation was considered too broad by the court.
Currently, no extended release
formulations are available on the European market.
Extended-release methylphenidate caused somewhat more insomnia (6.2%, compared with 2.3% in the atomoxetine group) and decreased appetite (5.8% versus 3%), but it also caused less nausea and somnolence (1.1% and 0.9%, respectively, in the extended release
methylphenidate group, compared with 4.9% and 4.2% in the atomoxetine group).
sales of Claritin-D(R) 12-Hour Extended Release
Tablets were approximately $320 million during the 12-month period ended September 30, 2000.
Northbrook, II, announced it has submitted a New Drug Application to the Food and Drug Administration (FDA) seeking approval for tacrolimus extended release
capsules for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.
According to the company, Trokendi XR is the first approved novel once-daily extended release
formulation of topiramate for the treatment of epilepsy.