Jubilant Life Sciences has received the final approval from the US health regulator for Darifenacin Extended-Release Tablets, used for the treatment of urinary incontinence condition.
- The company has “received Abbreviated New Drug Application (ANDA) final approval for Darifenacin Extended-Release Tablets, 7.5 mg and 15 mg, the generic version of Enablex of Allergan Plc, which is used for the treatment of urinary incontinence.
- Jubilant Life Sciences said it has received 6 approvals from the USFDA during the year.
- As on June 30, 2016, Jubilant Life Sciences had a total of 70 ANDAs for Oral Solids filed in the US, of which 44 have been approved. Shares of Jubilant Life Sciences were trading 1.56 per cent lower at Rs 641 on BSE.
DO YOU KNOW?
USFDA
- The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services.
- It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency.
- Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.
- FDA is responsible for: Protecting the public health by assuring that foods (except for meat from livestock, poultry and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and properly labeled.
- Ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective.
- Protecting the public from electronic product radiation; Assuring cosmetics and dietary supplements are safe and properly labeled; Regulating tobacco products.
- Advancing the public health by helping to speed product innovations.
Jubilant Life Sciences
- Jubilant Pharmaceuticals is the European subsidiary of Jubilant Life Sciences Ltd. (India), specialists in the R&D and production of API’s and finished dosage form products.
- We are a totally backward integrated service and product provider for generic pharmaceutical companies who wish to excel in first-to-market generics with a commitment to market-competitive prices during the entire term of the Supply Agreement.
