Cipla Secures CDSCO Panel Nod to Manufacture Amantadine Oral Solution with Trial Waiver
New Delhi: Drug major Cipla has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Amantadine Hydrochloride Oral Solution USP 50 mg/5 ml with bioequivalence study and clinical trial study waiver.
This came after the firm presented their proposal for the manufacturing and marketing of Amantadine Hydrochloride Oral Solution USP 50 mg/5 ml along with justification for waiver of clinical trial and bioequivalence study before the committee.
The committee noted that Amantadine Hydrochloride Oral Solution USP 50 mg/5 ml is classified as a BCS Class I drug and has been approved in the United States since 28.10.1994 for the treatment of Parkinsonism.
Amantadine is in a class of medications called adamantanes. It is thought to work to control movement problems by increasing the amount of dopamine in certain parts of the body. It works against influenza A virus by stopping the spread of the virus in the body.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.