Product News


ADHD Candidate Drug Abandoned Following Phase 3 Failure
After spotty trials, Alcobra's MDX met its end as a potential ADHD treatment.
Long-Acting Opioid Painkiller Gains FDA Approval
The FDA approved a morphine sulfate extended-release tablet (Arymo ER/Egalet) to treat severe pain needing “daily, around-the-clock, long-term opioid treatment".
Ranibizumab Approved by FDA for Myopic Choroidal Neovascularization
The FDA’s decision follows the EU’s decision last month to similarly expand the scope of the drug’s approval to include more specific causes of vision loss and blindness.
FDA Issues Refusal to File for Postoperative Pain Reliever's NDA Bid
Deeming Xaracoll to be a drug/device combination, the Food and Drug Administration notified Innocoll yesterday that it would not be going forward with the New Drug Application they had filed for the product in October.
FDA Rejects Solithromycin for Bacterial Pneumonia
The FDA has issued a complete response letter for the oral and intravenous antibiotic solithromycin as a treatment for patients with community-acquired bacterial pneumonia, due to concerns over hepatotoxicity and manufacturing issues.
FDA Approves Maci to Treat Cartilage Defects in the Knee
The FDA this week announced approval of Maci, “matrix-induced autologous chondrocyte implantation.” The treatment is intended for cartilage defects of the knee, which can eventually lead to osteoarthritis.
FDA Bans Powdered Surgical Gloves
Citing health hazards to patients and workers, the US Food and Drug Administration has issued a final rule banning the use of powdered exam gloves and surgical gloves. It will take effect January 19, 2017.

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