Formulary Watch |

FDA approves EpiPen rival

FDA approves first generic Truvada for HIV

FDA gives once-daily HIV therapy go-ahead

Asthma biologic may reduce oral steroid use

First generic Strattera for ADHD approved

Investigational drug appears beneficial in preventing migraines

Drugmaker recalls samples of antiplatelet drug

Combination pack approved for breast cancer treatment

Top 5 specialty drug management issues

How pharma reps impact physician prescribing

Amputation risk possible with diabetes drugs, FDA warns

Based on new data from 2 large clinical trials, FDA is warning that these blockbuster type 2 diabetes medications can cause an increased risk of leg and foot amputations.

FDA expands cystic fibrosis treatment

FDA expanded the use of ivacaftor (Kalydeco, Vertex Pharmaceuticals) to treat cystic fibrosis.

New FDA lead ushers in new era

Scott Gottlieb, MD, was sworn in as the new FDA commissioner and ushers in a new era.

Immuno-oncology bladder drug wins approval

Soon after approving the same drug for metastatic Merkel cell carcinoma, FDA approved immuno-oncology avelumab (Bavencio) for locally advanced or metastatic urothelial carcinoma.

Costly new ALS treatment approved

FDA recently approved the first new treatment for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, in more than 20 years.

Campaign gears up to combat high drug prices

Walmart, CVS Health, and a number of other healthcare organizations are supporting a new multi-million dollar consumer campaign to combat high prescription drug prices.

FDA approves first targeted leukemia drug for certain patients, plus 2 more

Late last week, FDA approved a new drug to treat acute myeloid leukemia (AML), the first treatment for Batten disease, and expanded the use of a current drug to treat liver cancer.

New abuse-deterrent opioid available

A new abuse-deterrent painkiller - oxycodone hydrochloride (RoxyBond, Inspirion Delivery Services) - will be available soon after receiving FDA approval.

FDA clears second Remicade biosimilar

In what is expected to produce hefty saving for rheumatoid arthritis patients and the healthcare system, FDA approved the second biosimilar to Remicade (Johnson & Johnson).

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.