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FDA Approvals, News & Updates

The FDA has approved Maci, the first tissue-engineered autologous cellularized scaffold product for the repair of symptomatic cartilage in adult patients with knee defects. Maci is composed of cells grown from the patient’s own healthy cartilage tissue, which are then placed onto a bioresorbable collagen membrane and surgically implanted over the area where the damaged tissue was removed.
On April 29, 2016, the FDA approved oxycodone (Xtampza ER) extended-release (ER) capsules, an opioid agonist, for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The US Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.
The US Food and Drug Administration (FDA) has approved etanercept-szzs, a biosimilar to etanercept (Enbrel), for the treatment of multiple inflammatory diseases, according to an announcement by the organization. The biosimilar injection has been approved to treat patients with moderate-to-severe rheumatoid arthritis; moderate-to-severe polyarticular juvenile idiopathic arthritis; active psoriatic arthritis; active ankylosing spondylitis; and chronic, moderate-to-severe plaque psoriasis.
The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients. Such mutations are present in approximately 10-20 percent of non-small cell lung cancers (NSCLC).
The U.S. Food and Drug Administration today approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs).
The U.S. Food and Drug Administration today approved Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy. Venclexta is the first FDA-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with CLL.
The US Food and Drug Administration (FDA) announced the approval of Inflectra (infliximab-dyyb)—a biosimilar to Remicade (infliximab)—for patients with chronic severe plaque psoriasis, and active ankylosing spondylitis or psoriatic arthritis. The biosimilar is also indicated for adult patients with moderately to severely active ulcerative colitis who have inadequately responded to standard therapy; in combination with methotrexate for patients with moderately to severely active rheumatoid arthritis; and patients aged ≥6 years with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Inflectra is the second biosimilar approved by the FDA.
Ixekizumab (Taltz) has been approved by the US Food and Drug Administration (FDA) for use in patients with moderate-to-severe plaque psoriasis, the agency has announced. Administered as an injection, ixekizumab is an antibody that binds and inhibits the inflammatory response of the inflammation-causing interleukin-17A protein.
Immediate-release opioid analgesics will now require boxed warnings regarding the serious risks for abuse, addiction, overdose, neonatal opioid withdrawal syndrome (NOWS), and death associated with the drugs, according to an announcement by the US Food and Drug Administration (FDA). This is the latest in a number of steps recently outlined by the FDA in their bid to reassess their approach to opioid medications.
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