USFDA

U.S. Food and Drug Administration expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery.
Melanoma, the most aggressive type of skin cancer, is the leading cause of death from skin cancer. Patients with stage III melanoma are generally treated by surgery to remove the melanoma skin lesions and the nearby lymph nodes.

The US Food and Drug Administration (FDA) has cleared Turing Pharmaceuticals AG's Investigational New Drug (IND) application for TUR-004 in the treatment of epileptic encephalopathies. In addition, TUR-004 has been granted Fast Track designation.

Lupin Pharmaceuticals Inc, a subsidiary of the company, has launched calcium acetate capsules having received final approval from the US health regulator. The drug is indicated for the control of hyperphosphatemia in end stage renal failure.

Endo Pharmaceuticals Inc., a subsidiary of Endo International plc, and BioDelivery Sciences International, Inc. (BDSI), a specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved Belbuca (buprenorphine) buccal film for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

U.S. Food and Drug Administration approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who previously received chemotherapy that contained anthracycline.

In consultation with the U.S. Food and Drug Administration (FDA), the U.S. Product Inserts (USPI) for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and TECHNIVIE™ (ombitasvir, paritaprevir, and ritonavir tablets) have been updated from 'not recommended in Child Pugh B patients' to a contraindication in patients with Child-Pugh B cirrhosis. The updated USPI for VIEKIRA PAK also includes a recommendation for physicians to assess evidence of hepatic decompensation prior to treatment and during treatment in cirrhotic patients.

Alexion Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Strensiq (asfotase alfa) for the treatment of patients with perinatal-, infantile- and juvenile-onset hypophosphatasia (HPP).

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US Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) voted 10 to 4 to recommend the approval of lesinurad 200mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI). All 10 who backed the drug, lesinurad, qualified their vote by urging the FDA to ask AstraZeneca for studies after the drug's launch to gauge its long-term effectiveness and safety.

Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market  Tramadol Hydrochloride Extended -release Tablets USP, 100 mg, 200 mg and 300 mg.