FDA Approvals

New Heart Failure Device Is Approved

THURSDAY, March 21, 2019 -- The Optimizer Smart System has been approved by the U.S. Food and Drug Administration for people with chronic, moderate-to-severe heart failure who are not candidates for other heart failure remedies.

"Patients with moderate-to-severe chronic heart failure have limited treatment options. And for those who are unable to be treated due to underlying conditions or who have not responded to available treatments, their quality of life may be impacted, with limits on the types of physical activities they can do," said Dr. Bram Zuckerman, director of the agency's Division of Cardiovascular Devices.

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Tecentriq Approved for Small Cell Lung Cancer

TUESDAY, March 19, 2019 -- Tecentriq (atezolizumab) has been approved by the U.S. Food and Drug Administration to treat adults with extensive-stage small cell lung cancer (ES-SCLC).

The drug has been approved as a first-line treatment for the disease, to be used in combination with the chemotherapy drugs carboplatin and etoposide.

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Spravato Nasal Spray Approved for Depression

WEDNESDAY, March 6, 2019 -- Spravato (esketamine) nasal spray has been approved to treat adult depression in cases where other antidepressants have failed, the U.S. Food and Drug Administration said Tuesday.

The drug's active ingredient is related to the club drug and anesthetic ketamine.

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First Customizable Insulin Pump Approved

FRIDAY, Feb. 15, 2019 -- The Tandem Diabetes Care t-Slim X2 insulin pump, which allows a patient to customize treatment, has been approved by the U.S. Food and Drug Administration.

"Diabetes is a complicated disease that requires close monitoring and carefully tailored treatments. We've heard from the patient community that having the ability to customize their own diabetes management devices is important to them," FDA Commissioner Dr. Scott Gottlieb said in an agency news release. "Advances in digital health make more tailored approaches to diabetes care possible."

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Cablivi Approved for Rare Clotting Disorder

WEDNESDAY, Feb. 6, 2019 -- Cablivi (caplacizumab-yhdp) injection has been approved by the U.S. Food and Drug Administration to treat adults with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and deadly disorder that causes blood clotting.

"Patients with aTTP endure hours of treatment with daily plasma exchange, which requires being attached to a machine that takes blood out of the body and mixes it with donated plasma and then returns it to the body. Even after days or weeks of this treatment, as well as taking drugs that suppress the immune system, many patients will have a recurrence of aTTP," said Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence.

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First Generic Version of Advair Diskus Approved for Asthma, COPD

THURSDAY, Jan. 31, 2019 -- The first generic form of the Advair Diskus (fluticasone propionate and salmeterol inhalation powder) inhaler has been approved by the U.S. Food and Drug Administration.

It can now be used to treat children aged 4 or older with asthma and adults with asthma or chronic obstructive pulmonary disease (COPD).

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First Generic Version of Epilepsy Drug Sabril Approved

THURSDAY, Jan. 17, 2019 -- The first generic version of Sabril (vigabatrin) has been approved by the U.S. Food and Drug Administration to prevent complex partial seizures in adults and children 10 and older with epilepsy.

"The availability of high-quality generic alternatives of critically important medicines, once the period of patent protection or exclusivity has ended on the brand drug, helps advance access and saves consumers billions of dollars each year," said FDA Commissioner Dr. Scott Gottlieb.

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Firdapse Approved for Rare Autoimmune Disorder

THURSDAY, Nov. 29, 2018 -- Firdapse (amifampridine) tablets have been approved by the U.S. Food and Drug Administration for adults with Lambert-Eaton myasthenic syndrome (LEMS).

It's the first agency-sanctioned treatment for the autoimmune disease that affects the connections between nerves and muscles.

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Truxima Approved as First Biosimilar to Non-Hodgkin's Lymphoma Drug

WEDNESDAY, Nov. 28, 2018 -- Truxima (rituximab-abbs) has been approved by the U.S. Food and Drug Administration as the first biosimilar to the non-Hodgkin's lymphoma drug Rituxan, the agency said Wednesday.

A biosimilar is a biological product that is approved based on data showing it is "highly similar" to a drug already approved by the FDA, with no "clinically meaningful differences in terms of safety, purity and potency," the agency said in a news release.

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Vitrakvi Approved for Cancers With Certain Genetic Trait

TUESDAY, Nov. 27, 2018 -- Vitrakvi (larotrectinib) has been approved by the U.S. Food and Drug Administration to treat cancers with a specific inherited trait called a biomarker.

The approval marks the second drug sanctioned to treat any type of cancer with a certain genetic feature, rather than the drug targeting a cancer that originated in a specific part of the body, the agency said in a news release.

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