Stay up-to-date on the latest drug news. Learn about new drug approvals, labeling changes, expanded indications, recalls, and approvals of generic formulations. These drug news updates are compiled from the latest information from Facts & Comparisons® and the U.S. Food and Drug Administration.
(Updated February 21, 2017)
The FDA has approved the following indications:
The FDA has approved the following expanded indications:
- Emflaza (deflazacort) oral tablets and oral suspension to treat patients age 5 years and older with Duchenne muscular dystrophy. Emflaza was approved under the FDA’s accelerated approval program.
- Siliq (brodalumab) subcutaneous injection for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and who are unresponsive or have lost response to other systemic therapies. Siliq was approved with a Risk Evaluation and Mitigation Strategy (REMS) and its prescribing information includes a Boxed Warning regarding the risk of suicidal ideation and behavior.
Recalls are actions taken by a company to remove a product from the market if it has been found to cause a serious adverse event. The following recalls have been announced:
- Spiriva Respimat (tiotropium bromide) inhalation spray to include use as a long-term, once-daily, maintenance treatment of asthma in patients 6 years and older. Spiriva Respimat was previously indicated as a maintenance treatment of asthma in patients 12 years and older. Spiriva Respimat is also indicated as maintenance treatment of chronic obstructive pulmonary disease.
- Exela Pharma Sciences, in association with X-Gen Pharmaceuticals, is voluntarily recalling 1 lot (PLND1613, expiration date February 2018, NDC 39822-1030-2) of ibuprofen lysine injection 20 mg/2 mL vials due to the presence of particulate matter is some vials. Customers with the affected lot should discontinue use. X-Gen is notifying its customers by email and fax and is arranging for product return. For additional assistance, customers may contact Exela at 1-888-451-4231; X-Gen at 1-866-390-4411; or email Recall@x-gen.us.
- Perrigo Pharmaceuticals is voluntarily recalling 10 lots of clindamycin phosphate/benzoyl peroxide gel (1.2%/5%) due to the presence of a small amount of mold on the caps of the tubes. The recalled lots are supplied as 45 g tubes: #080806 (Exp 12/16), #080844 (Exp 12/16), #080963 (Exp 12/16), #080999 (Exp 12/16), #084109 (Exp 03/17), #084197 (Exp 03/17), #091090 (Exp 10/17), #092319 (Exp 11/17), #092399 (Exp 12/17), #092440 (Exp 12/17). Distributors should quarantine any affected product immediately and remove from distribution. For additional information, customers may contact Perrigo at 800-321-0105 or visit http://www.perrigo.com.