Greenstone launches authorized generic of Silvadene Cream
Pfizer subsidiary Greenstone has introduced its authorized generic of Silvadene Cream (silver sulfadiazine cream, 1%). The drug is indicated as an adjunct to prevent and treat wound sepsis in patients with first- and second-degree burns.
Greenstone’s generic will be available in 50- and 85-g tubes, as well as in 50- and 400-g jars.
Aurobindo gets FDA approval for generic Arixtra
The Food and Drug Administration recently approved Aurobindo’s generic of Mylan’s Arixtra (fondaparinux sodium) injection. The company has planned January launch for the drug, which is indicated to prevent deep vein thrombosis.
Aurobindo’s generic will be available in single-dose prefilled syringes of 2.5 mg/0.5 ml, 5 mg/0.4 ml, 7.5 mg/0.6 ml and 10 mg/0.8 ml. The product’s market size was $73 million for the 12 months ended October 2017, according to IQVIA data.
Sun Pharma settles litigation over Linzess generic
Mumbai-based Sun Pharma has settled its litigation with Allergan and Ironwood Pharmaceuticals. The companies reached an agreement Tuesday to resolve litigation surrounding Sun’s submission of an abbreviated new drug application for a generic of Linzess (linaclotide capsules).
As part of the agreement, Allergan and Ironwood have granted Sun Pharma and its subsidiaries a license to market its generic of the treatment for irritable bowel syndrome treatment with constipation and chronic idiopathic constipation in the United States starting Feb. 1, 2031 or earlier under certain circumstances. The launch would be subject to Food and Drug Administration approval.
“Ironwood and Allergan have established Linzess as the branded prescription market leader in the IBS-C and CIC category,” Ironwood chief commercial officer Tom McCourt said. “We are pleased to have resolved this patent litigation with Sun Pharma, as we believe it confirms the strength of our Linzess intellectual property. Allergan and Ironwood are committed to continuing to grow the Linzessfranchise for many years to come.”