The agency said Cipla’s ANDA met all the requirements for approval, but also that there is increased demand for the products.
The US Food and Drug Administration suggested that its approval of the first generic version of Merck & Co. Inc.’s Proventil HFA (albuterol sulfate) metered dose inhaler may have at least some connection to the coronavirus outbreak.
Cipla Ltd.’s ANDA for the product, which is indicated for treatment or prevention of bronchospasm and exercise-induced bronchospasm, was...
Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.
Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.
Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.
Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.
Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.
Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.
Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.
