Generics
The US FDA’s approval of the first generic rival to Mayne Pharma’s Imvexxy (estradiol) comes days after the agency released product-specific guidance, which was demanded by the originator through citizen petitions.
CDER Office of Generic Drugs publishes MaPP for prescription-to-nonprescription switches and ANDAs to explain regulatory responsibilities for makers of generic copies of reference listed drugs approved for OTC switch.
Responding to the newly-agreed EU pharma package, Medicines for Europe said the deal was a limited political compromise that could have been more ambitious – particularly when it comes to access – but nevertheless represented “an important step forward” and “progress” for the EU pharma sector.
“Section viii cannot function as Congress intended,” if a Federal Circuit ruling stands, the US solicitor general has argued as he urged the Supreme Court to review and reverse the closely-watched Hikma skinny-label Vascepa case.
The US FDA has delivered its December batch of product-specific guidances for generic development, marking only the second timely release of the year.
Delaware district court refuses to shorten 30-month stay, leaving Hopewell unable to launch its generic Mavenclad product.
Cuban argues that user fees under the GDUFA program are deterring domestic production of generics, according to reports.
After years of fighting and securing treatment for her daughter, cystic fibrosis campaigner Gayle Pledger could not leave other patients behind. This is a story of families coming together and finding a generic drug manufacturer in order to save their children.
A Delhi High Court has declined Novo Nordisk’s bid to halt Reddy’s ongoing production, allowing exports while patent validity proceeds to trial.
The FDA said an ANDA managed to be submitted during a period when no new ANDAs could be accepted.
EPO Appeal Board overturns earlier ruling and invalidates Biogen’s 480mg Tecfidera patent, clearing the way for broader dimethyl fumarate competition in Europe.
ANDA sponsors received 20 days to pay fees associated with applications submitted during the government shutdown, while NDA and BLA sponsors only received five days.
Back-to-back FDA nods for generic Restasis and ProAir highlight Amneal’s growing strength in complex sterile and inhalation manufacturing.
The FDA proposed changes to the formal meeting system for sponsors in the next generic drug user fee program cycle, in part to speed timelines.
The European Commission says it will soon publish an updated study on the impact of the Urban Waste Water Treatment Directive on the pharmaceutical and cosmetics industry and that it would support member states in avoiding “unintended consequences.”
In announcement of approving VKT Pharma’s application, FDA included storage and handling instructions common in labeling, suggesting concerns persist about the potential for NDMA to form after products are distributed.
A webpage for PharmaTher’s ketamine product lacked risk information and made misleading claims about the approved indication, the FDA said in a rare ad/promo violation letter to an ANDA holder.
As Alvotech continues to reorganize its senior team with the promotion of chief scientific officer Joseph McClellan to chief operating officer, multiple other firms – including Hikma, Hyloris, CNX and Cingulate – have also announced executive updates.
The US FDA delivered its promise to publish product-specific guidances in November, after two late batches earlier this year. Third time might have been a charm, but it remains to be seen if the December batch will be the fourth time guaranteed.
During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.