Biocon gets USFDA approval for generic version of anti-cancer drug

Biocon said that it has received received tentative approval of its ANDA for Dasatinib tablets from the US FDA, for various strengths. This product is indicated for use in the treatment of Philadelphia chromosome positive chronic myeloid leukemia in adults. It is also used to treat Philadelphia chromosome positive acute lymphoblastic leukemia in adults with […]

Panacea Biotech’s Baddi unit gets OAI status from USFDA

Source: CNBCTV18 Panacea Biotech informed the exchanges that the United States Food & Drug Administration (USFDA) has classified the company’s Baddi facility in Himachal Pradesh as an “Official Action Indicated” (OAI). The facility was issued a form-483 by the drug regulator with nine observations in October, which were related to improvements in existing procedures. An […]