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A federal appeals court has upheld a lower court ruling that allowed Lupin to manufacture a generic of one of ViiV Healthcare’s HIV therapies, while blocking Teva’s ANDA of a related drug. Read More
Drugs containing the antihistamine hydroxyzine should be taken at the lowest effective dose for the shortest possible time to minimize heart risks, a drug safety committee in the EU says. Read More
The FDA last week granted final approval to Mylan and Watson for generic versions of Pfizer’s blockbuster arthritis drug Celebrex, allowing the companies to share 180-day exclusivity with Teva. Read More
The FDA on Friday issued long-awaited guidance for large drug compounding facilities, clarifying the types of companies that must register with the agency, plus providing additional labeling guidance for repackaging activities and adverse event reporting requirements. Read More
In observance of Presidents' Day, Drug Industry Daily will not be published Monday, Feb. 16. The next issue will be published Tuesday, Feb. 17. Read More
The drug pricing authority in India has published a compilation of the price caps for 509 drugs, effective Jan. 31, to give drugmakers a single source of pricing information. Read More
Mylan and Sandoz need only FDA approval to launch their generic versions of Teva’s blockbuster MS drug Copaxone, after a federal judge refused Teva’s request to block generic entry. Read More
Israeli drugmaker Teva says it has uncovered questionable business practices at its operations in Russia, Eastern Europe, Latin America and elsewhere, in violation of the Foreign Corrupt Practices Act, the U.S. antibribery law. Read More