Lawmakers seek to restore the availability of Primatene Mist while the absence of an alternative OTC asthma remedy persists.
FDA should release the existing supply of OTC asthma inhaler Primatene Mist so consumers have a nonprescription emergency treatment available until one can be developed that meets rules governing ozone-depleting chemicals, Rep. Mike Ross says.
The Arkansas Republican said 1 million inhalers are in a warehouse in California. “Americans are without an OTC emergency inhaler...
Create an account to read this article
Already a subscriber?
The billionaire investor said during a recent conference that brand drug manufacturers want to work with his Cost Plus Drug Co., but are afraid the PBMs will retaliate.
The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.
Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.
The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
After the abrupt departure of CBER’s director, it seems FDA, and Vinay Prasad in particular, would likely have been well served by hearing from an advisory committee before requesting the suspension in sales of Sarepta’s DMD gene therapy Elevidys.
Canadian politicians must “move quickly” to introduce policies that will speed up access to medicines, such as by broadening criteria for the temporary reimbursement of medicines, the Canadian Chamber of Commerce says.
The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.
