FDA Update: September 2016

Sep 9, 2016
Express Scripts Office of Clinical Evaluation and Policy tracks some recent updates to the drug pipeline.
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  • Pain
  • Cancer

New Pill Bottle

Express Scripts’ Emerging Therapeutics team monitors new drug approvals, new generics and other actions from the U.S. Food and Drug Administration (FDA). Here are some important approvals and updates we tracked over the past month:

Abuse-Deterrent Troxyca ER Approved

Troxyca® ER, an extended-release, abuse-deterrent formulation of oxycodone and naltrexone, was approved by FDA on Aug. 19, 2016. It is a CII opioid agonist/opioid antagonist combination that is indicated for continual maintenance treatment of severe pain not responding to other treatment options. When swallowed, the oxycodone in Troxyca ER releases slowly over several hours. If the capsules are crushed, however, the naltrexone and oxycodone mix together, essentially cancelling any euphoric effects from the oxycodone. Although Troxyca ER is formulated specifically to limit abuse, it still carries the boxed warning on all opioids – that taking it may be associated with abuse, addiction, misuse, overdose and death Troxyca ER will be marketed in six strengths and it is taken at 12-hour intervals. The manufacturer, Pfizer, recommends that a healthcare provider experienced in prescribing opioids to control chronic pain should prescribe the lowest effective dose of Troxyca ER. No release date or pricing information has been announced. Click here for complete prescribing information.

First Generic Approved for Tamiflu

The first generic for Roche’s Tamiflu® (oseltamivir) capsules was FDA approved on Aug. 3, 2016. Oseltamivir is indicated to treat influenza (flu) for patients who are at least two weeks old and who have had flu symptoms for no longer than two days. Patients take it twice a day for five days. For periods of up to 12 weeks, it also can be used to reduce the chance of getting flu for individuals who are at high risk and who are one year old or older. According to a lawsuit settlement, the generic manufacturer, Natco Pharma, and its U.S. distribution partner, Alvogen, can launch the generic capsules prior to the expiration of Tamiflu’s last exclusivity on Feb. 23, 2017. An exact release date has not been set, but Natco/Alvogen will have 180 days of exclusivity before other generics can enter the U.S. market. Generics for Tamiflu Oral Suspension are not yet FDA approved. IMS Health estimates that 2015 sales of Tamiflu accounted for $403 million in the United States.

Keytruda Labeling Extended

Under its accelerated approval process, FDA has approved a new indication for Merck’s Keytruda® (pembrolizumab). On Aug. 5, 2016, Keytruda received approval for patients who have recurring or metastatic head or neck squamous cell carcinoma (HNSCC). An intravenous (IV) drug, it will be used during or following platinum-based therapy that is not controlling the cancer. It previously was indicated for treating unresectable or metastatic melanoma and metastatic non-small cell lung cancer (NSCLC) that expresses PD-L1 and that has progressed during or after platinum-containing chemotherapy. NSCLC patients must be tested for PD-L1 before beginning Keytruda. To treat HNSCC, 200mg of Keytruda is infused over a 30-minute period once every three weeks. HNSCC patients will not need PD-L1 testing. Complete prescribing information is available here.

MedWatch Update: PharmaTech Recall Expanded

PharmaTech is a company that manufactures multiple oral liquid medications for distribution by other companies. Many of them are over-the-counter products, such as vitamin drops and laxative syrups. In mid-July, Burkholderia cepacia (B. cepacia) bacteria were found in samples of Diocto Liquid (docusate sodium) oral solution that were made by PharmaTech and distributed by Rugby® Laboratories. PharmaTech recalled all lots of Rugby-labeled Diocto at that time. On Aug. 8, 2016, PharmaTech extended the recall to include numerous other products distributed by Rugby, Bayshore Pharmaceuticals, Centurion Labs, Major® Pharmaceuticals, Metron and Virtus Pharmaceuticals. B. cepacia infections usually are not serious, but they can be life-threatening for patients with lung conditions or immune system disorders. Only oral liquid dosage forms of the recalled drugs and supplements are affected by the recall. More information, including a complete list of affected products, can be found here.

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