Aurobindo Pharma Ltd has said that the US FDA has lined up one of its oral solids formulation plants in Telangana for regulatory action, following adverse findings in an October inspection. The company’s shares had fallen by 19% in intra-day trading on October 8, soon after the company disclosed that FDA inspectors had made seven […]
Aurobindo Pharma said it received approval from the South African authorities to launch a key anti-HIV drug in the country, following the launch of the medicine in Sub-Saharan Africa. Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (DLT) tablets are the first-line, preferred regimen for HIV patients as per latest WHO guidelines, the company said. “Aurobindo is […]
Aurobindo Pharma Limited said it received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fondaparinux Sodium injection — a bioequivalent and therapeutic equivalent to Arixtra of Mylan Ireland. The product, used to prevent deep vein thrombosis (DVT), will be launched next month. “The approved product has an estimated market […]
Aurobindo Pharma said it received tentative approval for its for anti-HIV drug Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate under the U.S. President’s Emergency Plan for AIDS Relief or PEPFAR. The approved product is used for the treatment of HIV-1 infection along as a complete regimen in adults and pediatric patients weighing 40 kg and greater. […]
Aurobindo Pharma said it received final approval from the US Food & Drug Administration to manufacture generic version of kidney drug Renvela from Genzyme. Sevelamer Carbonate oral suspension, 0.8 gm and 2.4 gm is being launched immediately, the company said. The drug had a market size of US$140 million (Rs 900 cr) for the twelve […]
Aurobindo Pharma Limited, a pharmaceutical manufacturing company based in Hyderabad, said it received a tentative approval for HIV drug Dolutegravir from US Food & Drug Administration. It is the first FDA approval of a generic version of Dolutegravir. Through a tie up with ViiV and the Clinton Health Access Initiative, Inc., the product is expected […]
Aurobindo Pharma Limited said it received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Norethindrone Acetate Tablets USP, 5mg. Norethindrone Acetate Tablet is used in the treatment of endometriosis, uterine bleeding caused by abnormal hormone levels, and secondary amenorrhea. The approved product has an estimated market size of US$ […]
