Cipla gets USFDA nod for Medroxyprogesterone injectable

The company has received final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Medroxyprogesterone injectable 150mg/mL.

New Delhi: Drug firm Cipla on Monday said it has received the final nod from the US health regulator for its Medroxyprogesterone injectable for prevention of pregnancy.

The company has received final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Medroxyprogesterone injectable 150mg/mL.

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The product is a generic version of Pfizer's Depo-Provera, it added.

Depo-Provera is a well-known brand name for medroxyprogesterone acetate, a contraceptive injection for women that contains the hormone progestin. Depo-Provera is given as an injection every three months. Depo-Provera typically suppresses ovulation, keeping your ovaries from releasing an egg. Depo-Provera also thickens cervical mucus to keep sperm from reaching the egg.

Depo-Provera and its generic equivalents had US sales of around USD 159 million for the 12-month period ending November 2018, Cipla further said.

The injection is indicated only for the prevention of pregnancy.

Cipla Limited is an Indian multinational pharmaceutical and biotechnology company, headquartered in Mumbai. The company primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control and depression; other medical conditions.

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