Dr Reddy’s has received a further CRL from the US Food and Drug Administration over its application for a generic rival to Merck Sharp & Dohme’s NuvaRing contraceptive, along with a CRL for its version of Teva’s Copaxone.
Dr. Reddy's has received a complete response letter from the US Food and Drug Administration over the Indian firm’s US application for a generic version of
Merck Sharp & Dohme's NuvaRing (etonogestrel/ethinylestradiol) vaginal ring contraceptive brand.
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Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.
Some medicines may be subject to price rises that make them unaffordable if the burden of paying for extra wastewater treatment is not more fairly distributed across different industries, the Danish pharmaceutical industry association has warned.
The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.
Sandoz has revealed plans to streamline more biosimilar trials amid evolving regulatory moves towards minimizing the need for comparative efficacy studies. The disclosure was just one of many pipeline and portfolio updates provided as the firm delivered positive first-half results.
Aurobindo is confident its planned Lannett acquisition will pass US FTC scrutiny after an attempt to acquire Sandoz assets was called off in 2020 post a delay in approval. The deal could widen Aurobindo’s US manufacturing presence at a time when its US Q1 revenue saw a year-on-year decline.
While biosimilars have seen success in Europe, there are still plenty of areas in which policy improvements could solve problems for the market, according to a new Samsung Bioepis white paper. Adam Levysohn, the firm’s local head of commercial strategy, talks about the proposals.
