Seven months after GlaxoSmithKline’s Voltaren Arthritis Pain (diclofenac sodium) 1% topical gel was switched to non-prescription status in the US, two companies have begun shipping equivalent OTC versions to retailers.
Dr. Reddy's Laboratories and Perrigo have moved simultaneously to launch in the US over-the-counter equivalent versions of GlaxoSmithKline’s Voltaren Arthritis Pain (diclofenac sodium) 1% topical gel, following the reference brand’s switch from Rx prescription status to OTC by the US Food and Drug Administration earlier this year.
Having identified consumer health as its core area of focus, Perrigo lauded the “first-to-market store brand launch,” describing it as...
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.
Amneal has marked its entry into China after receiving its first product approval in the market. Meanwhile, the firm has also outlined US approvals for two generics currently suffering from shortages.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
