EAST WINDSOR, N.J. – Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application ursodiol capsules USP, 300mg. Aurobindo Pharma’s ursodiol capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Actigall Capsules, manufactured by Teva Branded Pharmaceutical Products R&D, Inc. Ursodiol capsules, are indicated
EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from the Food and Drug Administration for its Abbreviated New Drug Application for rhuzdah (norethindrone and ethinyl estradiol tablets, USP), 0.4 mg/0.035 mg. Rhuzdah is an AB-rated generic equivalent to the reference listed drug Ovcon-35, manufactured by Warner Chilcott Company, LLC. It is indicated
EAST WINDSOR, N.J. — Aurobindo Pharma announced the acquisition of a 239k sq.ft. manufacturing facility located in Caguas, Puerto Rico. The facility is designated for manufacturing oral solid dose products, both tablets and capsules, with both regular and high potency capabilities. Here some additional facility highlights below:
EAST WINDSOR, N.J. – Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application nebivolol tablets, 2.5mg, 5mg, 10mg, and 20mg. Aurobindo Pharma’s nebivolol tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Bystolic Tablets, of Allergan Sales. Nebivolol tablets are indicated for the
EAST WINDSOR, N.J. — Aurobindo Pharma has acquired a portfolio of assets comprised of 45 ANDA’s, which includes oral solid, dermatological, and injectable generic products. The products are not currently being marketed, though work has begun with regards to site and tech transferring the products to Aurobindo Pharma’s network of FDA approved facilities, as well
EAST WINDSOR, N.J. – Aurobindo has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application baclofen tablets USP, 10 mg and 20 mg. Aurobindo Pharma’s baclofen tablets USP, 10 mg and 20 mg, are an AB-rated generic equivalent to the reference listed drug (RLD),Loiresal of Novartis Pharmaceuticals Corp. Baclofen
EAST WINDSOR, N.J.— Aurobindo Pharma USA has launched emtricitabine/tenofovir disoproxil fumarate tablets 200mg/300mg, an AB-rated generic equivalent to the reference listed drug Truvada Tablets of Gilead. The tablets hav an estimated market size of $2.2B USD for the twelve months ending January 2021, as per IQVIA.
EAST WINDSOR, N.J. — Aurobindo Pharma has introduced generic midodrine hydrochloride tablets. Midodrine hydrochloride tablets USP, 2.5 mg, 5 mg, and 10 mg, are an AB-rated generic equivalent to the reference listed drug ProAmatine Tablets, of Takeda Pharmaceuticals U.S.A., Inc. Midodrine hydrochloride tablets has an estimated market size of $59.9M USD for the twelve months
EAST WINDSOR, N.J. – Aurobindo has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application fluoxetine tablets, 10 mg and 20 mg. Aurobindo’s fluoxetine tablets, 10 mg and 20 mg are an AB-rated generic equivalent to the reference listed drug, Prozac Tablets of Eli Lilly and Co. Fluoxetine is
EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application montelukast sodium oral granules USP, 4 mg. Montelukast sodium oral granules USP, 4 mg are an AB-rated generic equivalent to the reference listed drug, Merck Sharp & Dohme Corp.’s Singulair Oral Granules.
EAST WINDSOR, N.J. – Aurobindo has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application trazodone hydrochloride tablets, 50 mg, 100 mg, 150 mg, and 300 mg. Aurobindo’s trazodone hydrochloride tablets, 50 mg, 100 mg, 150 mg, and 300 mg are an AB-rated generic equivalent to the reference listed
EAST WINDSOR, N.J. – Aurobindo has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application oxycodone hydrochloride oral solution USP, 5 mg/5 mL (1 mg/mL) and 100 mg/5 mL (20 mg/mL). Aurobindo’s oxycodone hydrochloride oral solution USP, 5 mg/5 mL (1 mg/mL) and 100 mg/5 mL (20 mg/mL) are
EAST WINDSOR, N.J. – Aurobindo has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application methotrexate tablets USP, 2.5 mg. Aurobindo’s methotrexate tablets USP, 2.5 mg are an AB-rated generic equivalent to the reference listed drug (RLD), Rheumatrex Tablets, 2.5 mg, of DAVA Pharmaceuticals. Methotrexate tablets are indicated for:
EAST WINDSOR, N.J. – Aurobindo has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for fenofibric acid delayed-release capsules, 45 mg and 135 mg. Aurobindo’s fenofibric acid delayed-release capsules is an AB-rated generic equivalent to the reference listed drug, Abbvie’s Trilpix. Fenofibric acid delayed-release capsules are peroxisome proliferator-activated
