BRIDGEWATER, N.J. — Amneal Pharmaceuticals has begun rolling out indomethacin extended-release capsules, an anti-inflammatory pain relief medication.
The drug maker said Thursday that it has gained Food and Drug Administration approval for indomethacin ER capsules in a 75-mg strength effective Dec. 1, 2010, and that the product is available in 30-, 60-, 90- and 500-count sizes to meet the needs of various pharmacy segments and prescription dispensing options.
According to Amneal, the product is the generic equivalent of Merck’s Indocin SR. Annual U.S. sales of indomethacin ER capsules were $41.5 million as of October 2010, based on IMS Health market data, the company said.
"Introducing indomethacin ER in four different sizes is a direct reflection of Amneal’s customer-centric philosophy," stated Chirag Patel, president of Amneal. "Through close collaboration with our customers, we identified the most appropriate sizes to offer.
"Besides the commonly used 60-, 100- and 500-counts, we added 30-count and switched from 100- to 90-count for more efficient unit-of-use and mail-order dispensing," Patel explained. "We continuously work to demonstrate our commitment to delivering new products and services that best serve the needs of pharmacies and our mutual and ultimate customers, the patients."
