EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application memantine hydrochloride ER capsules, 7mg, 14mg, 21mg, and 28mg. Aurobindo Pharma’s memantine hydrochloride ER capsules, 7mg, 14mg, 21mg, and 28mg, are an AB-rated generic equivalent to the reference listed drug (RLD), Namenda
EAST WINDSOR, N.J. – Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application dorzolamide HCl and timolol maleate ophthalmic solution, 2% / 0.5%. Aurobindo Pharma’s dorzolamide HCl and timolol maleate ophthalmic solution, are an AT-rated generic equivalent to the reference listed drug (RLD), Cosopt Ophthalmic Solution,
EAST WINDSOR, N.J. – Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application potassium chloride extended-release tablets USP, 10 mEq, 15 mEq, and 20 mEq. Aurobindo Pharma’s potassium chloride extended release tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), potassium chloride extended
EAST WINDSOR, N.J. – Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application leflunomide tablets USP, 10 mg and 20 mg. Aurobindo Pharma’s leflunomide tablets USP,are an AB-rated generic equivalent to the reference listed drug (RLD), Arava Tablets marketed by Sanofi-aventis U.S. Leflunomide tablets, is indicated
EAST WINDSOR, N.J. — Aurobindo Pharma USA announces the launch of imatinib mesylate tablets 100mg and 400mg. Imatinib mesylate tablets, 100 mg and 400 mg, are an AB-rated generic equivalent to the reference listed drug Gleevec Tablets, 100 mg and 400 mg, of Novartis Pharmaceuticals Corp. Imatinib mesylate tablets has an estimated market size 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 Droxidopa Capsules, 100mg, 200mg, and 300mg. Aurobindo Pharma’s Droxidopa Capsules, 100mg, 200mg, and 300mg are an AB-rated generic equivalent to the reference listed drug (RLD), Northera Capsules 100mg, 200mg, and 300mg marketed
EAST WINDSOR, N.J. – Aurobindo Pharma has gotten final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Application azelastine hydrochloride nasal spray 0.15% (205.5 mcg per spray). Aurobindo Pharma’s azelastine hydrochloride nasal spray 0.15% (205.5 mcg per spray) are an AB-rated generic equivalent to the reference listed drug (RLD), Astepro
EAST WINDSOR, N.J. – Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application ketorolac tromethamine ophthalmic solution, 0.5%. Aurobindo Pharma’s ketorolac tromethamine ophthalmic solution, 0.5% are an AB-rated generic equivalent to the reference listed drug (RLD), Acular Ophthalmic Solution, 0.5% (Allergan, Inc.) Ketorolac tromethamine ophthalmic solution
EAST WINDSOR, N.J. — Aurobindo Pharma has launched generic tamoxifen citrate tablets. Tamoxifen citrate tablets USP, 10 mg and 20 mg are an AB-rated generic equivalent to the reference listed drug Nolvadex Tablets, 10 mg and 20 mg, of AstraZeneca Pharmaceuticals LP. Tamoxifen citrate tablets has an estimated market size of $22.69M USD for the
EAST WINDSOR, N.J. — Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Azelastine Hydrochloride Nasal Spray 0.15% (205.5 mcg per spray). Aurobindo Pharma’s Azelastine Hydrochloride Nasal Spray 0.15% (205.5 mcg per spray) are an AB-rated generic equivalent to the reference listed drug (RLD), Astepro Nasal Spray, 0.15%, of
EAST WINDSOR, N.J. – Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for aripiprazole oral solution, 1 mg/mL. Aurobindo’s aripiprazole oral solution is an AB-rated generic equivalent to the reference listed drug, Otsuka’s Abilify Oral Solution. Aripiprazole oral solution is indicated for the treatment of: Schizophrenia
EAST WINDSOR, N.J. — Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for Dofetilide Capsules, 0.125 mg, 0.25 mg, and 0.5 mg. Aurobindo’s dofetilide capsules are an AB-rated generic equivalent to the reference listed drug, Pfizer’s Tikosyn. Dofetilide capsules are indicated for the maintenance of normal sinus
EAST WINDSOR, N.J. — Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for eletriptan hydrobromide tablets, 20 mg and 40 mg. Aurobindo’s eletriptan hydrobromide tablets are an AB-rated generic equivalent to the reference listed drug, Pfizer’s RELPAX. Eletriptan hydrobromide is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated
EAST WINDSOR, N.J. — Aurobindo Pharma announces the signing of a definitive agreement to acquire a portfolio of seven branded oncology injectable products from Spectrum Pharmaceuticals Inc. The acquisition also brings-in an experienced branded commercial infrastructure in the U.S. Acrotech Biopharma, a wholly-owned subsidiary of Aurobindo Pharma USA Inc., which in turn a wholly-owned subsidiary of Aurobindo Pharma
