Generics
IDT Australia gets FDA nod for 23 generics
IDT Australia announced on 13 April 2015 that the US Food and Drug Administration (FDA) had accepted the transfer of ownership of 23 generics to the Australia-based company.
Brazilian patients positive about generics
A study looking at patients perceptions on generics in Brazil concludes that, although Brazilian patients have a positive attitude towards generics, more work is needed to increase the use of generics in the country.
Effectiveness of generic and originator gabapentin in lower back pain
Researchers from the Chulalongkorn University and the King Chulalongkorn Memorial Hospital in Bangkok, Thailand, carried out a study to compare the effectiveness of generic gabapentin Sandoz compared to originator gabapentin (Neurontin) [1].
France outlines plans to promote generics
The French are in general mistrusting of generics with many choosing to stay with brand-name drugs. However, in 2012, in order to combat rising healthcare costs, the French Government introduced measures to increase generic drug use in the country [1]. Now the government has gone a step further and is introducing a national action plan to encourage the use of generics in the country.
Comparison of generic and originator gabapentin
The cost of treatment for patients with neuropathic lower back pain is higher than those with non-neuropathic lower back pain. Originator gabapentin (Neurontin), an anticonvulsant, the efficacy has been proven for pain improvement among patients with neuropathic pain. In Thailand, gabapentin has usually been prescribed for patients having chronic back pain associated with lumbar radiculopathy, however, the high cost of originator gabapentin (Neurontin) has been found to be a problem for patients. Although generic gabapentin has recently been launched in Thailand, there is limited clinical evidence to prove its effectiveness compared to the originator.
Shire grabs Par’s attention with patent lawsuit
Shire has served its rival Par Pharmaceutical (Par) with a patent infringement lawsuit in New Jersey Federal Court over Par's application to market a generic version of Shire's attention deficit hyperactivity disorder medication Adderall XR.
Dr Reddy’s US drug pricing comes under scrutiny
Dr Reddy’s Laboratories, the India-based generics drugmaker, has been asked to share drug-pricing information with the attorneys general of California and Texas in November 2014. The two US States take their lead from an investigation into generics pricing at the national level.
Generics utilization policies necessary to sustain Medicaid
A review of the history and expansion of generics utilization policies and their critical role in the US Medicaid system in an era of reduced budgets concluded that such policies are a necessary component for preservation of the Medicaid system [1].
Actavis loses Atelvia patents
Teva Pharmaceutical Industries (Teva) has won a legal battle against Actavis after a federal judge invalidated two patents protecting the post-menopausal osteoporosis drug Atelvia (risedronate sodium delayed-release tablets, 35 mg). Actavis acquired Atelvia in 2013 when it bought Irish drugmaker Warner Chilcott [1], which continues to produce the drug as an Actavis subsidiary.
Health Canada clamps down on GMP compliance
Canada’s federal health department Health Canada has written to its licensed drug and active pharmaceutical ingredients (API) manufacturers worldwide reminding them of their regulatory responsibilities and obligations. The department plans to step up planned and unplanned inspections of facilities, with the aim of taking timely and appropriate action where needed.
