Abbott Gets CDSCO Panel Nod To Study Antidiabetic FDC Dapagliflozin plus Metformin
New Delhi: The drug major Abbott Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the bioequivalence (BE) study of the fixed-dose combination (FDC) of the antidiabetic drug Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin plus Metformin Hydrochloride IP (sustained released) (10mg+500mg/ 10mg+1000mg) film-coated tablets.
This came after Abbott Healthcare presented its proposal along with the BE study waiver justification of the FDC of the antidiabetic drug Dapagliflozin Propanediol monohydrate plus Metformin Hydrochloride film-coated tablets.
Dapagliflozin Propanediol is the propanediol form of dapagliflozin, a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Upon administration, dapagliflozin selectively targets and inhibits SGLT2, thereby preventing the reabsorption of glucose by the kidneys. Dapagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems.
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.