On 21 October, the US Food and Drug Administration (FDA) will meet to discuss plans for the second iteration of the Generic Drug User Fee Act (GDUFA II) under which FDA says it will begin offering ...
FDA cleared generic rifapentine for active pulmonary TB (≥12 years) with susceptible isolates, requiring combination therapy with other active antitubercular agents. Authorization also covers LTBI (≥2 ...
The FDA announced approval of generic Priftin tablets to treat two types of tuberculosis caused by Mycobacterium tuberculosis ...
Allowing the importation or reciprocal approvals of generic drugs for those with limited competition in the US could help the country better manage price spikes and shortages, researchers from Johns ...
The Food and Drug Administration said it will take steps to speed up the process of developing generic versions of complex biological drugs, in a bid to increase cheaper competition for expensive ...
Given the high stakes involved, the generic exclusivity period’s effects on competition should be scrutinized.
Rifapentine is a cyclopentyl rifamycin antimycobacterial agent indicated for the treatment of active pulmonary tuberculosis and late tuberculosis infection.
June 17 (Reuters) - The U.S. Food and Drug Administration approved the first generic version of Roche's Xofluza, a ...
Prior authorization is a standard process used by insurance companies to assess the safety, cost-effectiveness, and medical necessity of certain treatments. Certain medications, especially those on ...
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