Mylan’s recently FDA-approved Advair Diskus generic to be offered at 70% cost reduction to its reference drug, and 67% less than GSK’s generic version.
As complex drugs see little competition, the FDA will distribute guidelines to increase approvals of generic medicines for ‘economic stability’ and to bring affordable drugs to patients.
European generics industry faces opposition while pushing for the SPC manufacturing waiver to be altered so it allows for the production of drugs under patent for non-EU countries.
The FDA approved Teva's generic for Sabril, the first generic for the drug, as the agency continues to focus its efforts to approve generics that face little competition.
The Indian government seeks to boost local drug production by stipulating that the ‘local content’ of domestic products is 75% and 10% for those that are non-domestic.
Heavily indebted Teva says consolidating its global headquarters in Israel will generate “significant savings from a business and operations point of view”.
The US Court of Appeals for the Federal Circuit removed the injunction against Dr. Reddy’s, which prevented the company from selling its Suboxone generic.
Aspen will spend a record sum on transforming its Port Elizabeth manufacturing site, marking the ‘single biggest pharmaceutical investment’ in South Africa to date.
The FDA’s recent guidance on complex generics ‘increases clarity’ for Indian drugmakers targeting the US market, according to India Ratings and Research.
