Indian pharma major Lupin Ltd announced today that it received tentative approval from the United States Food & Drug Administration to market a generic version of Apotex Technology’s ‘Paxil’ Paroxetine tablets.
The medicine is indicated for the treatment of major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder.
Tentative FDA approvals do not allow companies to market the drug in the US. They are issued by the FDA before the patents on the original drug expires. Once the patent expires, the company is free to market the drug.
Paxil CR had US sales of $127.4 million.
Lupin is a pharmaceutical company which produces and develops branded & generic formulations, biotechnology products and APIs globally.
The Company also sells drugs in the cardiovascular, diabetology, tuberculosis, asthma, pediatric, central nervous system, etc.
For the financial year ended 31st March, 2016, Lupin’s Consolidated sales and Net profit stood at Rs 136,539 million ($2.09 billion) and Rs 22,607 million ($345 million) respectively.