Mumbai, India, June 21, 2018
Cipla Limited (“Cipla”), today announced that
it has received final approval for its Abbreviated New Drug Application (ANDA)
for Testosterone Cypionate Injection 100mg/ml and 200mg/ml from the United
States Food and Drug Administration (US FDA).
Cipla’s Testosterone Cypionate Injection 100mg/ml and 200mg/ml is AO-rated
generic therapeutic equivalent version of Pharmacia and Upjohn’s DepoTestosterone®.
It is indicated for replacement therapy in males in conditions
associated with symptoms of deficiency or absence of endogenous
testosterone.
According to IQVIA (IMS Health), Depo-Testosterone® and its generic
equivalents had US sales of approximately $191M for the 12-month period
ending April 2018.
The product is available for shipping immediately.
About Cipla:
Cipla is a global pharmaceutical company which uses cutting edge
technology and innovation to meet the everyday needs of all patients. For
over 80 years, Cipla has emerged as one of the most respected
pharmaceutical names in India as well as across more than 80 countries. Our
portfolio includes over 1500 products across wide range of therapeutic
categories with one quality standard globally.
Whilst delivering a long-term sustainable business, Cipla recognises its duty to
provide affordable medicines. Cipla’s emphasis on access for patients was
recognised globally for the pioneering role played in HIV/AIDS treatment as the
first pharmaceutical company to provide a triple combination anti-retroviral
(ARV) in Africa at less than a dollar a day and thereby treating many millions
of patients since 2001. Cipla’s research and development focuses on
developing innovative products and drug delivery systems. For more
information, please visit www.cipla.com
Media Contacts:
Corporate Communications
Pallavi Golar
E-Mail: pallavi.golar@cipla.com
