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).
Strides will have a 180 days of Competitive Generic Therapy (CGT) exclusivity for the product, under section 505(j)(5)(B)(v) of the FD&C Act.
Read also: Strides: Dr R Ananthanarayanan to depart as MD, Arun Kumar to take charge
The US OTC market for Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) is approximately ~US$ 41 Mn.
The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
The company has 274 cumulative ANDA filings (including recently acquired portfolio from Endo at Chestnut Ridge) with USFDA of which 251 ANDAs have been approved and 23 are pending approval. The company currently has ~60 commercialized products in the US and has set a target to launch ~ 20 new products every year from the combined portfolio.
Strides Pharma Science Singapore arm had earlier received USFDA approval for Ibuprofen Oral Suspension USP, 100 mg/5 mL.
Read also: Strides Pharma bags USFDA nod for pain relief drug
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.