Lupin gets USFDA approval for Ganirelix Acetate Injection
Ganirelix Acetate Injection is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.;
Mumbai: Global pharma major Lupin Limited has announced that the Company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Ganirelix Acetate Injection, 250 mcg/0.5 mL Single-Dose Prefilled Syringe, to market a generic equivalent to the reference listed drug (RLD), of Ganirelix Acetate Injection, 250 mcg/0.5 mL of Organon USA LLC.
Ganirelix is Lupin's first peptide-based injectable. The product will be manufactured at Lupin’s Nagpur facility in India.
Ganirelix Acetate Injection is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.
Ganirelix Acetate Injection had estimated annual sales of USD 84 million in the U.S. (IQVIA MAT September 2023).
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.