CURRENT AFFAIRS

Detailed explanation-1: -Lupin gets tentative USFDA nod for Dolutegravir, Emtricitabine and Tenofovir Alafenamide tablets.

Detailed explanation-2: -The drug firm said it has received approval from the US health regulator to market Doxycycline Capsules used to treat bacterial infections in the American market.

Detailed explanation-3: -The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Ivacaftor tablets, 150 mg strength, Lupin said in a statement. The product is the generic equivalent of Vertex Pharmaceuticals’ Kalydeco tablets, it added.

Detailed explanation-4: -A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. In the warning letter, it pointed out the company’s “failure to establish adequate written procedures for cleaning equipment and its release for use in manufacture of intermediates and API".