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news.Matrix Laboratories, a subsidiary of Mylan, an Indian-based company engaged in the manufacture of active pharmaceutical ingredients (APIs) and solid oral dosage forms, has received final approval from FDA for its abbreviated new drug application (ANDA) for Nabumetone tablets of strengths 500mg and 750mg.
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Nabumetone product is bioequivalent and, therefore, therapeutically equivalent to Nabumetone tablets. Nabumetone belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in joints and muscles to treat diseases such as osteoarthritis and rheumatoid arthritis.
Matrix Laboratories’ product will be marketed by Mylan Pharmaceuticals.
Mylan, currently holds 134 ANDAs pending FDA approval. Mylan claimed that 39 of these pending ANDAs are first-to-file opportunities.
Mylan is a generics and specialty pharmaceutical companies, providing products to customers in more than 140 countries and territories. Mylan operates a fully integrated specialty pharmaceutical business, Dey Pharma, which produces medicinal therapies, including EpiPen Auto-Injector.