TRP_1170x120_12-19-19

Aurobindo Pharma

Aurobindo gets FDA approval for aripiprazole oral solution

Aurobindo gets FDA approval for aripiprazole oral solution

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

Aurobindo receives FDA approval for dofetilide capsules

Aurobindo receives FDA approval for dofetilide capsules

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

Aurobindo gets FDA nod for eletriptan hydrobromide tablets

Aurobindo gets FDA nod for eletriptan hydrobromide tablets

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

Aurobindo’s Acrotech Biopharma to acquire oncology products from Spectrum Pharmaceuticals

Aurobindo’s Acrotech Biopharma to acquire oncology products from Spectrum Pharmaceuticals

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

Aurobindo receives FDA approval for letrozole tablets

Aurobindo receives FDA approval for letrozole tablets

EAST WINDSOR, N.J. – Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for letrozole tablets USP, 2.5 mg. Aurobindo’s letrozole tablets are an AB-rated generic equivalent to the reference listed drug, Novartis’ Femara. Letrozole is an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone

Aurobindo launches atazanavir capsules

Aurobindo launches atazanavir capsules

EAST WINDSOR, N.J. — Aurobindo Pharma has launched atazanavir capsules 100 mg, 150 mg, 200 mg and 300 mg upon receiving final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application. Aurobindo’s Atazanavir capsules are an AB-rated generic equivalent to the reference listed drug REYATAZ. Atazanavir capsules are indicated for

Aurobindo receives FDA approval for ertapenem injection

Aurobindo receives FDA approval for ertapenem injection

EAST WINDSOR, N.J. — Aurobindo Pharma announced that the company has received final approval from the U.S. Food & Drug Administration to manufacture and market ertapenem injection 1 g/vial. Aurobindo’s ertapenem injection is a generic equivalent of Merck Sharp & Dohme Corp’s Invanz Injection. The product will be launched in July 2018. The approved product

Aurobindo releases Nexium 24HR generic

Aurobindo releases Nexium 24HR generic

HYDERABAD, India — Aurobindo Pharma Ltd. has received Food and Drug Administration approval to manufacture over-the-counter 20-mg esomeprazole magnesium delayed-release capsules, an antacid. Aurobindo said its esomeprazole OTC product, being shipped immediately, is a generic version of Nexium 24HR capsules from Pfizer Consumer Healthcare. A proton pump inhibitor (PPI), Nexium 24HR capsules are indicated for

Aurobindo gets FDA approval for pair of new generics

Aurobindo gets FDA approval for pair of new generics

EAST WINDSOR, N.J. — Aurobindo Pharma Ltd. has received Food and Drug Administration approval for two new generic drug products: amlodipine and olmesartan medoxomil tablets, and glipizide extended-release tablets. Aurobindo said Monday that its amlodipine and olmesartan medoxomil product comes in dosages of 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40

Aurobindo cleared to market generic Xopenex

Aurobindo cleared to market generic Xopenex

EAST WINDSOR, N.J. — Aurobindo Pharma Ltd. has gained final approval from the Food and Drug Administration for levalbuterol inhalation solution in dosages of 0.31 mg/3 ml, 0.63 mg/3 ml and 1.25 mg/3 ml. The medication is used to treat breathing problems in patients with conditions such as asthma or chronic obstructive pulmonary disease (COPD).

Aurobino gets approval for Vicoprofen generic

Aurobino gets approval for Vicoprofen generic

DAYTON, N.J. — Aurobindo Pharma Ltd. has been cleared by the Food and Drug Administration to market hydrocodone bitartrate and ibuprofen tablets 7.5 mg/200 mg (C-II), a combination opioid and nonsteroidal anti-inflammatory drug (NSAID) painkiller. Aurobindo said its combination hydrocodone/ibuprofen product is a generic version of Vicoprofen tablets from AbbVie Inc. Hydrocodone bitartrate and ibuprofen

Natrol’s new supplements expand beauty lineup

Natrol’s new supplements expand beauty lineup

CHATSWORTH, Calif. — Natrol LLC has introduced three new dietary supplement products, its first launches since being acquired by Aurobindo Pharma USA Inc. The new offerings — Natrol Skin, Hair & Nails; Natrol Biotin Plus; and Natrol Extra Strength Turmeric — are slated to hit store shelves this month at select retailers nationwide, including Walgreens,

Aurobindo gets FDA OK for generics of Aygestin, Pepcid

Aurobindo gets FDA OK for generics of Aygestin, Pepcid

DAYTON, N.J. — Aurobindo Pharma Ltd. this week announced Food and Drug Administration clearance for a pair of new generic drugs, including women’s health and antacid products. On Wednesday, Aurobindo said it has received FDA approval for norethindrone acetate tablets 5 mg, a generic equivalent of Aygestin tablets from Duramed Pharmaceuticals. Norethindrone acetate tablets are