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The FDA is on track to top its fiscal year 2017 record for generic approvals despite receiving fewer ANDA submissions, according to the agency’s latest generic drug activities report. Read More
More than 70 million people around the world have been infected with HIV and some 35 million have died since the AIDS epidemic began, according to WHO statistics. Read More
Commissioner Scott Gottlieb said the approval is part of FDA’s “longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval.” Read More