Cipla receives USFDA approval for Generic Voltaren Gel
Sanjay Krishna | Myequity news | Date : 07-08-2018 16:10:00 IST
Cipla Limited announced that it has received final approval on August 3, 2018, for its Abbreviated New DrugApplication (ANDA) for Diclofenac Sodium Topical Gel, 1% from the United States Food and Drug Administration (USFDA).
Cipla’s Diclofenac Sodium Topical Gel, 1% is AB-rated generic therapeutic is equivalent to the reference listed drug (RLD), Voltaren Gel, 1% of GlaxoSmithKline Consumer Health®. The drug is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.
According to IQVIA (IMS Health), Voltaren Gel and its generic equivalents had US sales of approximately $353M for the 12-month period ending June 2018. The product will be available for shipping in the US in the upcoming week.About Cipla ltd :
Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio inour home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, anti-retroviral, urology,cardiology and CNS segments are well-known. Our 44 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products usingcutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Mar’18), 4th largest in the pharmaprivate market in South Africa (IQVIA MAT Jun’18), and is among the most dispensed generic players in the US. For over eight decades, making adifference to patients has inspired every aspect of Cipla’s work. Our paradigmchanging offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollara day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of themovement. A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of ‘Caring for Life’ and deep-rootedcommunity links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders.