Strides Pharma gets US FDA nod for naproxen sodium softgel capsules
The approval by the US Food and Drug Administration (FDA) is for naproxen sodium softgel capsules of 220 mg strength (over the counter)
Strides Pharma yesterday said its wholly-owned arm, Strides Pharma Global Pte, has received approval from the US health regulator for generic naproxen sodium softgel capsules, used to treat pain or inflammation.
The approval by the US Food and Drug Administration (FDA) is for naproxen sodium softgel capsules of 220 mg strength (over the counter), the company said in a regulatory filing.
It is bioequivalent and therapeutically equivalent to the Reference-Listed Drug (RLD), naproxen sodium capsules, 220 mg of Bionpharma Inc, it added.
The product will be manufactured at the company’s Bengaluru facility.
Naproxen sodium softgel capsules is a non-steroidal anti-inflammatory drug used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps, the company said.
Strides said it is focussing on building a private label business in the US by leveraging its portfolio of products across soft gels, tablets, capsules and other formats.
The US Over The Counter (OTC) market for naproxen sodium softgel capsules, 220 mg, is approximately $100 million, the company said.
Edits by EP News Bureau
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