7 FDA Approvals You Need to Know


Plus a "Better Care Reconciliation Act" wrap up and 2 bonus approvals from across the pond.

Between a handful of new approvals, some third-party recommendations, and the looming teardown of the American health care system, the FDA had a busy week. Here are the stories you need to know to stay in the loop.

EMDAC Recommends Liraglutide’s Approval to Reduce CV Risk in T2D Patients

An independent committee agreed that Novo Nordisk’s liraglutide (Victoza) injections decrease the risk of heart failure in patients with type 2 diabetes, but some members of the panel recommended that the drug's indication be limited only to T2D patients who had established cardiovascular disease.

FDA Approves VTE Prevention Drug Betrixaban

Portola Pharmaceuticals’ betrixaban (BEVYXXA) received approval for the prophylaxis of venous thromboembolism (VTE) in hospitalized acute medical illness adult patients.

FDA Approves Herditary Angioedema Attack Treatment

FDA Approves ADHD Treatment Mydayis

Now that it’s approved, CSL Behring, LLC’s Haegarda will allow patients to experience easier at-home self-injections from the prevention of Hereditary Angioedema (HAE). The FDA gave the green light to Shire Pharmaceuticals' NDA of mixed salts of a single-entity amphetamine product for the treatment of ADHD.

FDA Approves ADHD Treatment Cotempla XR-ODT

Another ADHD drug received approval this week — Neos Therapeutics’ Cotempla XR-ODT, an orally disintegrating tablet formulation of central nervous system stimulant methylphenidate.

FDA Approves Delafloxacin for Bacterial Skin Infection Treatment

Melinta Therapeutics received approval for delafloxacin (Baxdela), a new antibacterial drug to treat acute bacterial skin and skin structure infections

FDA Accepts NDA for Fostamatinib Disodium

Rigel Pharmaceuticals received approval for the NDA of fostamatinib disodium (TAVALISSE) for patients with chronic or persistent immune thrombocytopenia.

Senate Majority Proposes the Better Care Reconciliation Act

The Senate majority repeal to Obamacare was unveiled under a bill titled “The Better Care Reconciliation Act" (BCRA).

AbbVie’s Glacaprevir/Pibrentasvir Recommended for EMA Approval

MAVIRET, an investigational, pan-genotypic treatment for adults with chronic hepatitis C virus (HCV) infection came a step closer to European approval after a sub-committee recommended that it receive market authorization from the European Medicines Agency (EMA).

MAA for Migraine Treatment Erenumab Accepted for Review

The EMA accepted a marketing authorization application for the first anti-calcitonin gene-related peptide treatment for migraine prevention.

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