Cipla receives final approval for generic version of Pfizer’s Depo-Provera (Medroxyprogesterone Injectable, 150mg/mL)

Cipla Limited has recently received final approval for its Abbreviated New Drug Application (ANDA) for Medroxyprogesterone Injectable, 150mg/mL from the United States Food and Drug Administration (US FDA). Cipla's Medroxyprogesterone Injectable, 150mg/mL is AB-rated generic therapeutic equivalent version of Pfizer's Depo-Provera. It is a progestin indicated only for the prevention of pregnancy. According to IQVIA (IMS Health), Depo -Provera and its generic equivalents had US sales of approximately $159M for the 12-month period ending November 2018.

Depo-Provera is an injectable form of contraception. Each injection protects the user from pregnancy for 3 months. It works by inhibiting the hormones that are needed for the release of eggs from the ovaries. The drug also helps to stop the growth of cells outside the uterus in case of endometriosis. Interestingly, Depo-Provera is also used in the treatment of certain types of cancer including cancer of the breast, kidney and endometrium (lining of the uterus), but is not considered as a cure for cancer. Its mode of action is through inhibition of the growth of these types of cancer cells.

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in emerging and regulated markets. Its paradigm-changing offer of a triple anti -retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the movement.