FDA Updates

Benlysta is the first approved treatment for children with lupus. 

Eticovo (etanercept-ykro) is a TNF blocker, biosimilar to Enbrel (etanercept). 

New lotion from Ortho Dermatologics expected June 2019. 

DUAKLIR PRESSAIR (aclidinium bromide and formoterol fumarate) provides LAMA/LABA therapy.

Diacomit (stiripentol) is indicated for rare, severe form of pediatric epilepsy.

Indicated for adults with moderate to severe plaque psoriasis.

Esketamine comes with close supervision requirements. 800 clinics have already been approved and dispensed initial applications. 

FDA granted final approval to drug originally tentatively approved in 2018.

The FDA has recently approved new dosage form and two new indications for the drug. 

Safety alert issued requiring warning about concurrent alcohol use.

Evenity (romosozumab-aqqg) has been approved to treat postmenopausal women at high risk of bone fractures.

Women no longer require nine months of contraception post cessation of the drug.

First-ever dual-drug, single tablet for HIV offers lighter treatment regimen. 

Solriamfetol is approved for adult patients suffering from the effects of narcolepsy and OSA. 

The next-generation oral drug is the first to be approved specifically for secondary progressive multiple sclerosis in more than 15 years.

First drug approved for PPD use to remain under REMS program.

Ongoing valsartan shortages due to recalls prompt FDA prioritization.

Indicated for breast cancer, and gastric or gastroesophageal junction adenocarcinoma. 

Eli Lilly creates generic Humalog priced 50% lower 

Restricted implants indicated for maintenance of opioid dependency. 

Sublingual form approved for short-term use.

The new device will increase real-time personalization and predictive diagnostics for patients.

Anthelmintic tablet for patients 6 years of age and older.

What you need to know about the von Willebrand factor (vWF)-directed antibody fragment.

What you need to know about the new botulinum toxin product.