Strides Pharma Ibuprofen Oral Suspension gets USFDA okay
Bengaluru: Strides Pharma Science Limited has recently announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC) from the United States Food & Drug Administration (USFDA).
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Infants' Advil Concentrated Drops, 50 mg/1.25 mL (40 mg/mL) (OTC), of GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu.
The Product approval further strengthens Strides Ibuprofen franchise for the US markets. Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA and is the "first approved applicant" for Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC).
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.