Lupin gets FDA approval for Diazepam Injection, USP
It is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.
It is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.
Lupin Limited has received tentative FDA approval for Enzalutamide Tablets in four strengths, including two additional dosing options beyond the traditionally available Xtandi tablet strengths.
Lupin has launched Azilsartan Medoxomil Tablets, the generic version of Edarbi, for the treatment of hypertension and will receive 180 days of market exclusivity as the first-to-file applicant.
The U.S. FDA has approved Lupin and Natco’s generic version of Halaven Injection, a cancer therapy with annual U.S. sales of approximately $43.7 million.
Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL, is bioequivalent to the reference listed drug (RLD), Ravicti® Oral Liquid, 1.1 grams per mL, of Horizon Therapeutics U.S. Holding LLC.
The tablets are bioequivalent to Farxiga®.
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This technology allows for easier injection with smaller needles and more consistent drug concentrations.
Lupin's partnership program is designed to foster collaborations with companies looking to extend their product lifecycles.
The facility will produce vital respiratory medicines and bolster the company’s role as a global respiratory leader.
Ipratropium bromide nasal solution (Nasal Spray), 0.03% and 0.06% are bioequivalent to Atrovent Nasal Spray, 0.03% and 0.06%, of Boehringer Ingelheim Pharmaceuticals.