Aurobindo gets tentative FDA ok for lopinavir/ritonavir
This article was originally published in Scrip
Aurobindo Pharma has received tentative US FDA approval for lopinavir/ritonavir tablets 100/25mg and 200/50mg, generic versions of Abbott Laboratories' antiretroviral Kaletra tablets. This is the first tentative approval of a generic version of Kaletra under PEPFAR (President's Emergency Plan for AIDS Relief). Aurobindo, which recently entered a licensing and supply deal with Pfizer for a range of generics (scripnews.com, March 4th, 2009), now has 93 ANDA approvals (66 final and 27 tentative approvals) from the FDA.
You may also be interested in...
Private equity group Carlyle has acquired 20% of Piramal's pharma business for close to $500m, with the Indian group expected to use the capital raise to bolster organic and inorganic growth and deleverage the balance sheet.
Fujifilm Toyama seals three-way deal to accelerate the development and global supply of favipiravir, close on the heels of the arrival of a generic version of the antiviral in India under restricted emergency use for the treatment of COVID-19.
Glenmark’s innovation spin-out initiates efforts to raise capital in the US, unfazed by mixed top-line results for its investigational atopic dermatitis treatment. Its parent firm has underscored the value proposition of the oncology franchise and proprietary bispecific antibody technology platform.