Formulary Watch |

FDA: Limit codeine and tramadol use in kids

FDA said this week that it is restricting the use of codeine and tramadol medicines in children. The drug’s labels will now include a contraindication that codeine should not be used to treat pain or cough, and that tramadol should not be used to treat pain, in children younger than 12 years.

Potential blockbuster arthritis drug delayed

Citing safety concerns, FDA delayed approval of a new blockbuster drug to treat rheumatoid arthritis.

Hep C drugs approved for kids

FDA approved supplemental applications for 2 primary hepatitis C medications to be used in children for the first time.

Drug prolongs IPF life expectancy: Study

Two recent studies demonstrate that pirfenidone (Esbriet, Genentech) prolongs life expectancy by 2.47 years for IPF patients and that Esbriet and nintedanib (Ofev, Boehringer Ingelheim) reduce the decline in lung function.

Novel drug approved for Huntington's symptom

FDA recently approved deutetrabenazine (Austedo, Teva Pharmaceuticals) to treat chorea associated with Huntington’s disease (HD). The medication is only the second product approved to treat HD, and is the first deuterated product approved by FDA.

First progressive MS drug carries high price tag

While FDA just approved the first drug for primary progressive multiple sclerosis (PPMS), the drug’s price tag is controversial.

Major EpiPen recall issued

Meridian Medical Technologies, Mylan's manufacturing partner for the EpiPen Auto-Injector, expanded a voluntary recall of the EpiPen and EpiPen Jr. epinephrine auto-Injectors to now include additional lots distributed in the United States and other markets.

First drug for rare skin cancer wins approval

FDA approved the first treatment for metastatic Merkel cell carcinoma (MCC), a rare, aggressive skin cancer.

New Parkinson's drug, 2 others approved

FDA approved safinamide (Xadago, Newron Pharmaceuticals) tablets as an add-on treatment for patients with Parkinson’s disease. FDA also approved new treatments for classical Hodgkin lymphoma and pemphigus vulgaris, a rare, life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.

Gottlieb FDA nomination praised

Pharmaceutical manufacturers and some consumer groups praised President Donald Trump’s nomination of Dr. Scott Gottlieb as the new FDA commissioner.

Generic versions of major depression drug available

Mylan received approval from FDA to market its desvenlafaxine extended-release tablets, the generic version of Pristiq (Pfizer), for major depressive disorder. Plus, 2 other manufacturers recently received approval for their generic versions of Pristiq.

Once-daily diabetes drug approved

FDA approved 10 mg dapagliflozin and 5 mg saxagliptin (Qtern, AstraZeneca), to treat type 2 diabetes.

Drug approved for nighttime urination, plus two more

FDA recently approved three novel drugs: one to treat frequent urination at night, one to treat carcinoid syndrome diarrhea in cancer patients, and one for dust mite allergies. Here are the details on the three new treatments.

HIV dual therapy shows promise

A dual-drug regiment to treat HIV could soon be a reality, according to results presented at the recent Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.

Tests help aid in antibiotic control

FDA recently approved 2 tests that will aid healthcare providers in determining which antibiotics are needed, leading to better antibiotics management.

Psoriasis drug approved with boxed warning

A new drug to treat moderate-to-severe plaque psoriasis carries a black box warning that suicidal ideas and behavior, including completed suicides, have occurred in patients during the drug’s clinical trials.

Popular asthma inhaler now expanded to kids

A leading asthma inhaler will now be available to additional younger asthma patients, after FDA approved Spiriva Respimat (Boehringer Ingelheim) for the long-term, once-daily maintenance treatment of asthma in people age 6 and older.

Muscular dystrophy drug launch halts after pricing concerns

Marathon Pharmaceuticals is temporarily pausing the launch of its drug to treat a rare form of muscular dystrophy (MD) after concerns over its $89,000 price tag.

New bladder cancer, kidney disease therapies available

FDA recently approved 2 new therapies: an expanded drug indication for locally advanced or metastatic urothelial carcinoma (mUC) and a treatment for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Major allergic reactions linked to common antiseptics

FDA is warning about rare but serious allergic reactions have from the widely-used skin antiseptic products containing chlorhexidine gluconate.

Diabetic patients challenge insulin makers

In the latest flap over the high cost of drugs, diabetes patients filed a class-action lawsuit against insulin makers.

Will Trump’s FDA picks speed drug approvals?

Three candidates that President Donald Trump is considering for FDA Commissioner are likely to speed drug approvals, analysts say.

First therapy approved for rare blood cancer

FDA recently granted accelerated approved for ibrutinib (Imbruvica, Janssen, Pharmacyclics), the first treatment for patients with a certain type of lymphoma.

Drug distributor pays record fine

McKesson Corp., one of the largest distributors of pharmaceuticals, agreed to pay a record civil penalty for alleged violations of the Controlled Substances Act.

Constipation drug wins approval

FDA approved plecanatide (Trulance, Synergy Pharmaceuticals) for adults with chronic idiopathic constipation.

Long-acting opioid painkiller wins approval

FDA recently approved a long-acting opioid designed to deter abuse.

Trump's drug pricing comments create debate

While President-elect Donald Trump recently said that the pharmaceutical industry is “getting away with murder” in terms of drug prices, the industry is trying to self-regulate before facing tighter rules from the incoming administration.

FDA approves hemophilia A drug for children

FDA recently expanded the use of antihemophilic factor (recombinant), pegylated (Adynovate, Shire plc) for hemophilia A patients under 12 years old.

New 340B drug rule sets drugmaker fines

Consumer health groups are praising Health and Human Services’ (HHS) new rule on the Medicaid 340B drug discount program, which sets a ceiling on drug prices.

New device could be breakthrough for diabetics

FDA recently expanded approval of the G5 Mobile Continuous Glucose Monitoring System (Dexcom) to allow for replacement of fingerstick blood glucose (sugar) testing for diabetics.