Biocon Pharma gains tentative USFDA nod for Parkinson's disease capsules
Bengaluru: Biocon has announced that Biocon Pharma Limited, a wholly owned subsidiary of the Company, has received tentative approval from the U.S Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) for Carbidopa and Levodopa Extended-Release Capsules, in 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg, and 61.25 mg/245 mg strengths.
Carbidopa and Levodopa Extended-Release Capsules are indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
Parkinson disease is a brain condition that causes problems with movement, mental health, sleep, pain and other health issues. It gets worse over time. Common symptoms of the disease include tremors, painful muscle contractions and difficulty speaking.
Parkinson results in high rates of disability and the need for care. Many people with it also develop dementia.
The disease usually occurs in older people, but younger people can also be affected. Men are affected more often than women. The cause of the disease is unknown but people with a family history of the disease have a higher risk. Exposure to air pollution, pesticides and solvents may increase risk.
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Biocon Limited, publicly listed in 2004, is a global biopharmaceutical company. It has developed and commercialized novel biologics, biosimilars and complex small molecule APIs in India and several key global markets, as well as generic formulations in the US and Europe.
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