The approval is for Levofloxacin in 5 percent Dextrose injection in the strengths of 250 mg/50 ml, 500 mg/100 ml, and 750 mg/150 ml, single use containers, Aurobindo Pharma said in a BSE filing.
Aurobindo Pharma today said it has received the US health regulator's approval to sell its generic Levofloxacin injection, used to treat infections, in the American market.
Glenmark Pharmaceuticals today said it has settled litigation with Janssen Pharmaceuticals Inc over patent actions regarding generic oral contraceptive Norgestimate and Ethinyl Estradiol tablets.
Pharma major Glenmark on Tuesday said its US generics arm has settled a litigation with Janssen Pharmaceuticals over patent actions concerning Norgestimate and Ethinyl Estradiol tablets in various strengths.
Lupin's subsidiary Lupin Pharmaceuticals Inc has received US Food and Drug Administration approval to sell Norgestimate and Ethinyl Estradiol tablets in various strengths.
Glenmark Pharma's US Generics arm has received final approval from US Food and Drugs Administration for its abbreviated new drug application (ANDA) for oral contraceptive Norgestimate and Ethinyl Estradiol tablets 0.25/0.035 mg strength.