Company becomes sole first applicant for 45 mg strength, positioning itself for potential 180-day generic exclusivity in the US market
Company introduces bioequivalent version of Edarbi for hypertension treatment following U.S. FDA approval; product recorded annual U.S. sales of USD 53.5 million
The approved product is therapeutically equivalent to Haldol tablets of Ortho McNeil Pharmaceutical
Approval for generic version of Xeljanz enables immediate launch and strengthens Aurobindo’s U.S. portfolio with its 586th ANDA approval
The approved product is the generic equivalent of Sutab® Tablets developed by Azurity Pharmaceuticals
Approved product is therapeutically equivalent to Synthroid of AbbVie and is indicated for the treatment of congenital or acquired hypothyroidism
Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States
The product is approved as bioequivalent to Xigduo XR for the indications outlined in the reference drug’s labelling
No adverse events reported; recall involves 5 mg 500-count bottles in the US market
Approval for 5 mg and 10 mg strengths, bioequivalent to Farxiga®, strengthens Lupin’s anti-diabetic portfolio in US market
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