USFDA

Sun Pharmaceutical Industries Ltd  announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for deuruxolitinib, an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2, for the treatment of adults with moderate to severe alopecia areata. In the NDA, Sun Pharma has submitted 8mg twice daily regimen of deuruxolitinib for FDA review.

Strides Pharma Science Limited announced that its step- down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Efavirenz (600mg), Emtricitabine (200mg), Tenofovir Disproxil Fumurate (300mg), (EET) tablets from the United States Food & Drug Administration (USFDA).

Strides Pharma Science Limited announced that its step‐ down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received tentative approval for its New Drug Application (NDA) 505b2 of Dolutegravir/ Lamivudine/ Tenofovir Disproxil Fumurate 50mg/ 300mg/ 300mg tablets from the United States Food & Drug Administration (USFDA). The Product will be manufactured at the company’s facility in Bengaluru.

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg (RLD: Accutane® Capsules, 10 mg, 20 mg and 40 mg: RS: Claravis 10 mg, 20 mg, 30 mg and 40 mg).

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Food and Drug Administration granted regular approval to pralsetinib (Gavreto, Genentech, Inc.) for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.