EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application solifenacin succinate tablets, 5mg, and 10mg. Aurobindo Pharma’s solifenacin succinate tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), VESIcare Tablets, manufactured by Astellas Pharma US, Inc. Solifenacin succinate
EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application dicloxacillin sodium capsules USP, 250mg and 500mg. Aurobindo Pharma’s dicloxacillin sodium capsules are an AB-rated generic equivalent to the reference listed drug (RLD), Pathocil Capsules, manufactured by Wyeth Ayerst Laboratories. Dicloxacillin sodium
EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application nifedipine extended-release tablets USP, 30mg, 60mg, and 90mg. Aurobindo Pharma’s nifedipine extended-release tablets USP, 30mg, 60mg, and 90mg, are an AB-rated generic equivalent to the reference listed drug (RLD), ADALAT CC of
EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Tobramycin inhalation solution, 300 mg/5 mL. Aurobindo Pharma’s Tobramycin Inhalation Solution, 300 mg/5 mL are an AB-rated generic equivalent to the reference listed drug (RLD), Tobi Inhalation Solution, 300 mg/5 mL marketed
EAST WINDSOR, N.J.— Aurobindo Pharma Limited and COVAXX, a U.S.-based company, have entered into an Exclusive License Agreement to develop, commercialize and manufacture UB-612, the first Multitope Peptide-based Vaccine to fight COVID-19, for India and the United Nations Children’s Fund (UNICEF) agency. COVAXX is currently conducting a Phase 1 clinical trial for the vaccine candidate.
EAST WINDSOR, N.J. – Aurobindo Pharma Limited has acquired clorazepate dipotassium tablets 3.75mg, 7.5mg and 15mg from Mylan Pharmaceuticals, a Viatris Co.. Mylan has agreed to transfer the FDA-approved ANDA for each of these products to Aurobindo Pharma USA, Inc. and Aurobindo will begin to market, distribute, and sell these products as of January 1,
EAST WINDSOR, N.J. — Pharma Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for ritonavir tablets USP, 100 mg. Aurobindo’s ritonavir tablets are an AB-rated generic equivalent to the reference listed drug, AbbVie Inc.’s Norvir. Ritonavir is in a class of medications called protease inhibitors. Protease
EAST WINDSOR, N.J. — Aurobindo Pharma Limited has launched sildenafil sitrate tablets 25 mg, 50 mg, and 100 mg upon receiving final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application. Aurobindo’s sildenafil citrate tablets are an AB-rated generic equivalent to the reference listed drug Viagra. The new sildenafil citrate tablets are
EAST WINDSOR, N.J. — Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for capecitabine tablets USP, 150 mg, and 500 mg. Aurobindo’s capecitabine tablets USP are an AB-rated generic equivalent to the reference listed drug Xeloda. Capecitabine tablets are indicated for the treatment of
