Australia laga Mayne Pharma para India laga Sun Pharma ke sue kurishey

Australia, 25 July : Mayne Pharma para Sun Pharma laga khilaf lawsuit file kurishey, patents laga infringements karney kuntu menopause-related vaginal pain karney ekta product dey related asey, itu Australian drugmaker para Thursday dey kuishey. New Jersey karney United States District Court dey itu lawsuit file kuria dey, Mayne Pharma para rival ke sob 20 Orange Book-listed patents violate kuria aarop kurishey kuntu IMVEXXY dey linked asey – ekta vaginal insert kuntu menopause piche dey sexual intercourse homoi pain komti kuriboley karney asey. Orange Book-listed patents toh U.S. Food and Drug Administration (FDA) para approve kuria khan asey aro chulawoley safe asey. Itu Australian drugmaker para ekta notification piche dey itu lawsuit file kurishey kuntu para indicate kurishey ki  FDA ke Sun Pharma para IMVEXXY laga ekta generic version market kuriboley approval mangina Abbreviated New Drug Application (ANDA) submit kurishey. Itu ANDA toh ekta request asey kuntu health regulator ke file kurey, ekta licensed drug medication ke manufacture kuriboley approval mangiboley, United States dey. Itu application processes para applicant ke ekta clinical trial kuriboley warrant nakurey. Sun Pharma para comment kuriboley Reuters laga request dey immediately jawaab dianai. Mayne Pharma laga complaint para bhi indicate kurishey ki Sun Pharma para ekta Paragraph IV certification file kurishey, itu latter ke suggest kurishey ki Orange Book  dey itu patent laga (IMVEXXY) listing ke invalid nahuiley inapplicable kuina challenge kuriboley. IMVEXXY ke TherapeuticsMD para distribute kurey aro 2018 dey FDA laga approval seal kurishey.