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FDA approves painkiller made by Sun Pharmaceutical Industries


MUMBAI, India — The Food and Drug Administration has approved a generic painkiller made by Sun Pharmaceutical Industries, Sun said.

Sun announced the approval of tramadol hydrochloride extended-release tablets, a generic version of Valeant International's Ultram ER. The drug is used to treat moderate to moderately severe chronic pain in adults who need constant treatment for an extended period of time.

Various versions of the drug have annual sales of $125 million, according to Sun.

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