Formulary Watch |

Pacira makes nice with FDA; encouraging for Exparel

Amicable resolution between FDA and Pacira Pharmaceuticals, Inc., which reaffirms the broad indication for Exparel (bupivacaine liposome injectable suspension).

Why manufacturer is recalling hospital blood pressure drug

Hospital pharmacies need to check their supplies of norepinephrine after PharMEDium Services in Lake Forest, Ill., voluntarily recalled several lots of Norepinephrine Bitartrate. The product is used to control blood pressure in certain acute hypotensive states.

5 things to know about the new gout drug

In late December, FDA approved AstraZeneca’s Zurampic (lesinurad) 200-mg tablets in combination with a xanthine oxidase inhibitor (XOI) for high levels of uric acid in the blood (hyperuricemia) associated with gout.

Expanded age indication cleared for Gardasil 9 in males

FDA approved expanded age indication for Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9, Merck) in males.

FDA approves drug for rare lung disease

The FDA recently granted orphan drug approval to Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation.

Pricing report blasts asthma drug cost

In the latest controversy over drug pricing, an organization said that the price of GlaxoSmithKline’s Nucala (mepolizumab), an injectable indicated for severe asthma patients with eosinophilic inflammation, is far over-priced.

Keytruda approved as first-line melanoma treatment

Sales of Merck’s Keytruda (pembrolizumab) are expected to increase, after FDA approved the drug for first-line treatment of melanoma.

First “follow-on” insulin glargine product approved to treat diabetes

FDA approved insulin glargine injection (Basaglar, Eli Lilly) to improve glycemic control in patients with diabetes mellitus.

How to help IPF patients – from their point of view

Pete Mulliner, an IPF patient and ambassador for the Pulmonary Fibrosis Foundation, discusses how he believes physicians should treat patients who have been recently diagnosed with IPF.

Long-awaited surgery drug gets FDA OK

FDA approved Bridion (sugammadex) injection today – after a long wait by Merck & Co. – to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, used during certain types of surgery.

Valeant responds to drug price concerns with cuts

Valeant Pharmaceuticals just entered into a new fulfillment agreement with Walgreens and says it will reduce prices of its branded prescription-based dermatological and ophthalmological products such as Jublia by 10 percent.

5 things to know about the new lung cancer drug

FDA granted accelerated approval to Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

Xarelto reduces hospital stays: Study

Hospital stays were shorter for patients treated with Xarelto (rivaroxaban) in a new study, compared to those receiving standard anticoagulants.

First chemotherapy antidote available soon

Wellstat Therapeutics Corporation said that its Vistogard, just approved by FDA as the first and only antidote for emergency treatment of adult and pediatric patients following an overdose of the chemotherapy, will be available on the U.S. market soon.

IPF drug to be tested with add-on therapy

Boehringer Ingelheim recently began a clinical trial to assess the safety and tolerability of adding on pirfenidone to Ofev (nintedanib) for idiopathic pulmonary fibrosis patients.

Serious risks associated with SGLT2 inhibitors

FDA is warning about ketoacidosis and urinary tract infections associated with the relatively new class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors such as Invokana and Jardiance.

FDA approves the first recombinant von Willebrand factor

FDA has approved recombinant von Willebrand factor (Vonvendi, Baxalta) for use in adults who have von Willebrand disease.

FDA approves chewable pill for pediatric ADHD

FDA has approved methylphenidate hydrochloride (QuilliChew ER, Pfizer) extended-release chewable tablets for the treatment of ADHD in children.

FDA approves first drug for adults, children with rare enzyme disorder

Genetically engineered chickens were needed to produce Kanuma (sebelipase alfa), newly approved by FDA to treat lysosomal acid lipase deficiency (LAL-D), a genetic and progressive ultra-rare metabolic disease in which patients suffer multi-organ damage and premature death.

Two states to allow pharmacists to prescribe birth control

Pharmacists in California and Oregon will soon be able to prescribe birth control.

Manufacturer-Foundation partnership to increase PF research

The Pulmonary Fibrosis Foundation and Boehringer Ingelheim’s new five-year partnership, aims to raise awareness of pulmonary fibrosis, provide disease education and advance care and funding research for the PF community

Hepatitis C drugs come under fire again

A new US Congressional report about the price of hepatitis C drug Sovaldi, along with a new class action lawsuit against Blue Cross Blue Shield involving Harvoni coverage, are the latest in a series of controversies surrounding the 2 drugs.

FDA approves a new immune-stimulating drug to treat multiple myeloma

FDA has approved elotuzumab (Empliciti, Bristol-Myers Squibb and AbbVie) for the treatment of multiple myeloma.

Older diabetic patients often overprescribed

A study published in the October 26th issue of the JAMA Internal Medicine journal shows that physicians don't typically reduce older patients' diabetic medications, even when the patients have low blood sugar levels.

Mount Sinai diabetes program uses “smart data”

A new joint program with the Mount Sinai Health System and Livongo Health, a consumer digital health company, is expected to help diabetics manage their disease better.

5 things to know about the new seasonal flu vaccine

FDA approves Portrazza for specific type of lung cancer

In its latest round of cancer drug approvals, the FDA last week approved Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC).

Opdivo approved for patients with metastatic renal cell carcinoma

FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of patients with metastatic renal cell carcinoma.

Top 6 things to know about anthrax vaccine

FDA this week approved a new indication for BioThrax to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease.

Top 5 things to know about new myeloma drug

In FDA’s latest approval of a new medication to treat multiple myeloma, the agency approved Ninlaro capsules, the first and only oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy