New Delhi: The drug major Akum Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the fixed-dose combination (FDC) of the Alcohol plus Ketoprofen Gel.
This came after Akum Pharmaceuticals presented its proposal along with the Phase III clinical trial study report before the committee.
Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID). It works by blocking the release of certain chemical messengers that cause fever, pain, and inflammation (redness and swelling).
Ketoprofen is used for pain relief. It relieves pain and inflammation in conditions like rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, gout, muscle pain, low back pain, and toothache.
Ketoprofen is also sometimes used to treat juvenile rheumatoid arthritis (a type of arthritis that affects children), ankylosing spondylitis (arthritis that mainly affects the spine), Reiter's syndrome (a condition in which many parts of the body including the joints, eyes, genitals, bladder, and digestive system become swollen), shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint) and tendinitis (inflammation of the tissue that connects muscle to bone), and gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints).
ketoprofen plus alcohol gel is indicated for symptomatic relief of pain in such conditions as soft tissue injuries, including sports injuries, sprains, strains, muscle tendonitis, swelling, backache, and rheumatic pain.
At the recent SEC meeting for Analgesic and Rheumatology held on 5th October 2023, the expert panel reviewed the proposal presented by the drug major Akum Pharmaceutical along with the Phase III clinical trial study of the FDC.
After detailed deliberation, the committee recommended the grant of permission for the manufacturing and marketing of the proposed FDC..
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