Drug Approvals

First Marijuana-Based Drug Approved to Treat LGS, Dravet Syndrome

First Marijuana-Based Drug Approved to Treat LGS, Dravet Syndrome

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This marks the first approved drug that contains an active ingredient derived from marijuana as well as the first treatment approved for patients with Dravet syndrome.

Post-Op Pain Treatment Gets Breakthrough Therapy Designation

Post-Op Pain Treatment Gets Breakthrough Therapy Designation

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The Company indicated that they will work towards an New Drug Application submission for the treatment in the second half of 2018.

Novel Antibiotic for <i>C Difficile</i> Infection Gets FDA's QIDP Designation

Novel Antibiotic for C Difficile Infection Gets FDA's QIDP Designation

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ACX-362E is a targeted, narrow spectrum oral antibiotic that blocks the DNA replication process through inhibition of polymerase III, which has been shown to be bactericidal.

FDA Approves Non-Opioid Treatment for Opioid Withdrawal

FDA Approves Non-Opioid Treatment for Opioid Withdrawal

Lucemyra is an oral selective alpha 2-adrenergic receptor agonist

First-of-Its-Kind Migraine Drug Receives FDA Approval

First-of-Its-Kind Migraine Drug Receives FDA Approval

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The efficacy of Aimovig was evaluated as a preventive treatment of episodic or chronic migraine in 3 randomized, double-blind, placebo-controlled studies: 2 studies in patients with episodic migraine (4-14 migraine days per month) and 1 study in patients with chronic migraine (≥15 headache days per month with ≥8 migraine days per month).

FDA Expands Use of MS Drug to Include Children

FDA Expands Use of MS Drug to Include Children

Gilenya is the first multiple sclerosis drug approved for children

Parkinson Drug May Be Linked to Deaths

Parkinson Drug May Be Linked to Deaths

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The FDA advisory committee voted 12-2 in favor of recommending the approval of Nuplazid.

Switching from Branded to Authorized Generic Drugs Linked to Lower Switchback Rate

Switching from Branded to Authorized Generic Drugs Linked to Lower Switchback Rate

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Switching back to branded drugs is more likely in generic drug than authorized generic drugs.

FDA Approves Multi-Cancer Treatment Drug

FDA Approves Multi-Cancer Treatment Drug

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The FDA has approved Rubraca, a poly (ADP-ribose) polymerase inhibitor, to treat patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Fycompa sNDA Submitted for Pediatric Seizure Indications

Fycompa sNDA Submitted for Pediatric Seizure Indications

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The proposed pediatric indications are based on a 2018 Draft Guidance that supports extrapolating efficacy data of approved drugs to treat POS in adults to pediatric patients aged ≥4 years.

NCCN's anticancer drug recommendations beyond FDA approval based on weak evidence

NCCN's anticancer drug recommendations beyond FDA approval based on weak evidence

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Does weak evidence drive the NCCN recommendations of FDA-approved drugs?

FDA OKs new medication for individuals with resistant HIV

FDA OKs new medication for individuals with resistant HIV

A new antiretroviral HIV treatment, Trogarzo (ibalizumab-uiyk), has been approved by the FDA for patients with HIV who have not have success with past HIV medications.

FDA approves new "follow-on" insulin for diabetes

FDA approves new "follow-on" insulin for diabetes

The new FDA approved short-acting insulin drug can be used to treat T1 and T2 diabetes.

FDA approves Tresiba, Ryzodeg for diabetes treatment

FDA approves Tresiba, Ryzodeg for diabetes treatment

The FDA has approved two new treatments, Tresiba and Ryzodeg, for both type 1 and type 2 diabetes.

FDA approves second nonstatin drug to treat patients with high cholesterol

FDA approves second nonstatin drug to treat patients with high cholesterol

The drug is approved for patients who are unable to control their LDL cholesterol with current treatment options.

Oxycontin for 11-year-olds? I'm okay with it

Oxycontin for 11-year-olds? I'm okay with it

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The FDA approval of a pediatric indication for Oxycontin creates a safer situation for terminally ill children.

OxyContin approved for children aged 11 and older

OxyContin approved for children aged 11 and older

The FDA has approved a pediatric indication for OxyContin in patients as young as 11 years.

Nonsurgical weight loss procedure receives FDA approval

Nonsurgical weight loss procedure receives FDA approval

An intragastric balloon receives approval as a non-surgical weight loss procedure for patients with mild-to-moderate obesity.

FDA approves two new therapies for irritable bowel syndrome

FDA approves two new therapies for irritable bowel syndrome

Two new therapies to treat irritable bowel syndrome, eluxadoline and rifaximin, have been approved by the FDA.

Raplixa approved to help control surgical bleeding

Raplixa approved to help control surgical bleeding

Spray-dried fibrin sealant promotes clotting when other methods are "ineffective or impractical."

FDA approves expands use of diabetic retinopathy drug

FDA approves expands use of diabetic retinopathy drug

The FDA has granted expanded the use of Eylea injection to treat diabetic retinopathy in patients with diabetic macular edema (DME).

Cresemba approved for serious fungal infections

Cresemba approved for serious fungal infections

New drug targets cell walls of the fungi and is available in oral and intravenous formulations.

First internal use tissue adhesive earns FDA approval

First internal use tissue adhesive earns FDA approval

The FDA has approved Cohera Medical's TissuGlu Surgical Adhesive, the first tissue adhesive for internal use.

Empagliflozin/linagliptin tablets approved for type 2 diabetes

Empagliflozin/linagliptin tablets approved for type 2 diabetes

The FDA has approved empagliflozin/linagliptin tablets as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when both empagliflozin and linagliptin are appropriate treatments.

First generic esomeprazole approved by FDA

First generic esomeprazole approved by FDA

The FDA has approved esomeprazole magnesium delayed-release capsules, the first generic version of AstraZeneca's Nexium.

Novel combo hypertension drug gets FDA nod

Novel combo hypertension drug gets FDA nod

Perindopril arginine and amlodipine besylate may be used as initial therapy if a patient is likely to need multiple drugs to achieve their blood pressure goals.

Secukinumab earns FDA approval for plaque psoriasis

Secukinumab earns FDA approval for plaque psoriasis

Secukinumab has been approved by the FDA for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Novel anticoagulant Savaysa gets FDA nod

Novel anticoagulant Savaysa gets FDA nod

Savaysa (edoxaban) is indicated to treat deep vein thrombosis and pulmonary embolism and prevent stroke.

Saxenda earns FDA approval for weight management

Saxenda earns FDA approval for weight management

The FDA has approved Saxenda (liraglutide [rDNA origin]) injection for chronic weight management.

Peramivir earns FDA approval to ease flu symptoms in adults

Peramivir earns FDA approval to ease flu symptoms in adults

Patients given paramivir had flu symptoms ease 21 hours sooner compared with patients left untreated.

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