Lupin receives FDA approval for generic Temovate Ointment, 0.05%
Mumbai, Baltimore, May 07, 2018: Pharma major Lupin announced that it has received final approval for its Clobetasol Propionate Ointment USP, 0.05% from the United States Food and Drug Administration (FDA) to market a generic version of Fougera Pharmaceuticals Inc.’s Temovate Ointment, 0.05%.
Lupin’s Clobetasol Propionate Ointment USP, 0.05% is the AB rated generic equivalent of Fougera Pharmaceuticals Inc.’s Temovate Ointment, 0.05%. It is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Clobetasol Propionate Ointment USP, 0.05% had annual sales of approximately 120 million in the US (IQVIA MAT January 2018).
About Lupin Limited
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.
Lupin is the 11th and 7th largest generics pharmaceutical company by market capitalization (December 31st, 2017, Bloomberg) and revenues (September 30th, 2017, Bloomberg LTM) respectively. The Company is the 4th largest pharmaceutical player in the US by prescriptions (IQVIA MAT December 2017); 2nd largest Indian pharmaceutical company by global revenues (September 30th, 2017, Bloomberg LTM); 6th largest generic pharmaceutical player in Japan and 5th largest company in Indian Pharmaceutical Market (IQVIA MAT December 2017).
For the financial year ended 31st March, 2017, Lupin’s Consolidated sales and Net profit stood at Rs. 171,198 million (USD 2.55 billion) and Rs. 25,575 million (USD 381 million) respectively. Please visit http://www.lupin.com for more information. You could also follow us on Twitter – www.twitter.com/lupinlimited
CIN: L24100MH1983PLC029442 Registered Office: Lupin Ltd, 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.
For further information or queries please contact –
VP – Corporate Communications
Ph: +91-22-66402531 / 8291013225
Head – Investor Relations
Temovate is a registered trademark of Fougera Pharmaceuticals Inc