Misuse and Abuse of Opioids: FDA Takes A Call

Mar. 11 | Opioid drugs provide significant benefits for patients when used properly for their approved indications. These are important pain medications that are widely prescribed for both non-cancer and cancer-related pain. However, opioids also carry a risk of...

Unanimous OK to Novartis’ Cushing’s Drug From FDA

Dec. 18 | The US Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted unanimously in support of the use of Signifor (pasireotide) for the treatment of patients with Cushing’s disease who require...

Lannett Received FDA Approval For Butalbital, Acetaminophen And Caffeine Tablets USP

Oct. 4 | Lannett Company, Inc. confirmed that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Butalbital, Acetaminophen and Caffeine Tablets, USP, 50mg/325mg/40mg. According to IMS, for...

U.S. FDA Lifts Sales Ban As Indian Pharma Companies Take Corrective Actions

Oct. 2 | Most Indian drug companies that were penalised for violating U.S. drug manufacturing norms in the last few years but have subsequently taken corrective actions are being allowed to resume sales by the US drug regulator. The U.S. Food and Drug Administration...

FDA Backed Abbott’s Humira For Colitis

Sep. 24 | The benefits of using Abbot Laboratories (ABT) rheumatoid arthritis drug Humira for patients with a type of ulcerative colitis outweigh the risks. Advisers to the Food and Drug Administration (FDA) had voted 15-2 in support of Humira’s use in those...

FDA Approved New Blood Test To Improve Prostate Cancer Detection

Aug. 7 | Beckman Coulter, Inc., the leader in prostate cancer diagnostics, announced Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the Prostate Health Index (phi), a simple, non-invasive blood test that is 2.5-times more specific...

FDA Approved Tudorza Pressair

Aug. 7 | The U.S. Food and Drug Administration (FDA) approved Tudorza (TM) Pressair (TM) (aclidinium bromide inhalation powder) of Forest Laboratories, Inc. for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease...

FDA Approved Novartis AG’s Afinitor For Breast Cancer

Aug. 7 | The US Food and Drug Administration (FDA) has approved Afinitor® (everolimus) tablets for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ breast cancer) in combination with exemestane...

Actos Of Takeda Pharma Linked To Bladder Cancer

Jul. 11 | In June 2011, the FDA required a new safety label stating that “the use of Actos for more than one year may increase a person’s chance of bladder cancer”. The French Medicines Agency conducted a study of 155,000 patients over four years which revealed...

Johnson & Johnson Seeks Approval of Canagliflozin, A Diabetes Pill

Jul. 11 | Johnson Research & Development has announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of canagliflozin, an investigational, oral, once-daily, selective sodium glucose...