FDA approves first generic albuterol drug for bronchospasm

The first generic drug Proventil HFA (Albuterol Sulfate) metered-dose inhaler, 90 mcg / inhalation, is approved by the Food and Drug Administration (FDA) for the treatment or prevention of bronchospasm in four-year-old patients or older who have reversible obstructive airway disease as well as exercise-induced bronchospasms in this age group.

“The FDA acknowledges the increased demand for albuterol products during the new coronavirus pandemic,” said FDA Commissioner Dr. Stephen M. Hahn. “We are deeply committed to facilitating access to medical products to help address the critical needs of the American public,” added the doctor.

According to the National Heart, Lung, and Blood Institute, bronchospasms occur when the muscles around the airways swell and harden, tightening the airways, making them narrower. Exercise and other physical activities can cause symptoms in most people who have asthma, and this can occur during or immediately after being active. Asthma causes recurrent episodes of wheezing (a wheezing sound when breathing), chest tightness, shortness of breath, and cough. The cough worsens at night or early in the morning. Asthma affects people of all ages, but it often begins during childhood. In the United States, more than 26 million people are known to have asthma, and about 7 million of these are children.

The most common side effects associated with Albuterol Sulfate Metered-Dose Inhaler, 90 mcg / Inhalation, are upper respiratory tract infection, rhinitis, nausea, vomiting, rapid heart rate (tachycardia), tremor, and nervousness.

The FDA regularly takes steps to help guide the industry through the development process for generic products, including complex combination products, such as metered-dose inhalers, which consist of a medication and a device. The development of many generic combination products may be more difficult than that of oral solid forms, such as tablets.

Under the Generic Drug User Fee Modifications (GDUFA), individual companies may collaborate with the FDA as part of its New Drug Abbreviated Forms (ANDA) program. to assist in the development of such complex generic pharmaceuticals. The FDA also publishes guidance documents that describe the FDA recommended steps that companies must follow to submit complete applications for generic pharmaceuticals.

In March 2020, the FDA released a revised draft of a specific product guide for proposed generic albuterol sulfate metered-dose inhalers including pharmaceuticals that reference Proventil HFA. Among other things, the draft guide provides bioequivalence recommendations.

The FDA requires applicants to submit adequate information and data to demonstrate that the complex generic drug-device meets the agency’s rigorous approval standards. These standards ensure high-quality generic pharmaceuticals that are as safe and effective as equivalent brand name drugs.

The FDA granted approval of this generic albuterol sulfate inhalation spray to Cipla Limited.

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Church of Fort Worth, offices closed for the week as positive presumptive chief pastor test for Coronavirus – NBC 5 Dallas-Fort Worth

The Trinity Episcopal Church in Fort Worth closed its building and offices for the week after a member of their church leadership tested the supposed positive for COVID-19.

Robert Pace, 53, remains in hospital in solitary confinement, church leaders confirmed Wednesday. According to Rev. Janet Wagoner with the episcopal diocese of Fort Worth, Pace has been part of the Fort Worth congregation since December.

“His spirit is strong. He is cheerful,
fun loving and deeply spiritual man who takes care of people like you don’t
to believe. People give it back, of course, “Rev. Wagoner told NBC 5.” I think our faith communities are uniquely equipped for
come around people and support people when this kind of thing happens and us
we are honored to have this type of role in our community where we have
networks and support systems. “

Pace is the first alleged positive case in Tarrant County. After initial discussions with public health officials this week, church officials said the rest of the congregation is not at risk.

According to the episcopal diocese of Fort Worth, Pace
participated in the consortium of gifted episcopal parishes (CEEP) in its annual
conference in Louisville, Kentucky, February 19 to February 22.

In a letter posted on the church’s website, Pace said he started feeling bad around Ash on Wednesday night.

“The beginning of Lent for me was one for the record books. I
I “involuntarily” fasted for days and days, and I certainly did
I said intercessory prayers. All this because I had a virus
that some time has come around the evening of Ash Wednesday. With high fever, a
horrible, painful cough and a little nausea, this was humiliating. But I am
finally getting better, ”said the letter.

Katie Sherrod, communications director for the episcopal diocese of Fort Worth, said she was informed by the public
Health officials that Pace’s presence at Ash Wednesday church services
the premises were not a concern, because it was then asymptomatic.

Pace tested negative for the flu twice a day after Ash Wednesday. The next time he was in church premises, on Wednesday, March 4, for a Lenten program.

“That particular night program, that is when he was here –
this is what Tarrant County public health focuses on, ”Church said
communications director Sarah Martinez. “Basically they just want to achieve
to the people who were at that event and what I was told is that they simply are
reach out and ask people to monitor their health. “

At NBC 5 all the hard surfaces in the Pace offices are told and the commonly touched surfaces were swept away after the March 4 event – along with the music stand, microphone, chair and piano bench. His exposure to anyone within a meter of him was also very limited, say church leaders.

Martinez told NBC 5 that no public health official was entrusted with the decision to cancel Sunday services this week. It was a decision by church leaders over an abundance of caution, he said.

Crews are already cleaning the church and offices day and night on alternate days. There is also a hand sanitizer available, along with many areas for hand washing.

“The public health people of Tarrant County were fantastic – they phoned me for a very long and detailed conversation, which put many worries at ease,” he said, referring to a Tuesday night conversation. “[They] they told me, there is no reason for any kind of deep cleaning, sanitizing of the church premises “.

The church
it was a polling place on Super Tuesday, particularly in its Parish Hall. On the
on election day, Pace had not been in the church building or office for
five days. Election officials provided tables, chairs and election materials
– not the church.

Next door
the church building is a nursery school, which is on vacation this week. Diocese
officials say that none of the children had any exposure to Pace.

Rev. Wagoner
says Pace’s wife, Rev. Dr. Jill Walters, tested negative for COVID-19, but
will remain in self-quarantine at home for 14 days. He encouraged people
who may know individuals currently isolated or self-quarantined to reach
via SMS or phone call, if possible, so they didn’t feel alone.

“This is a time when we really need the community and the information
and speaking of information, we really have to make sure we share it well
information including material from the public health department and the CDC “,
Wagoner said.

The Lenten program scheduled for Wednesday evening has been canceled.

To read the full version of the episcopal diocese of Fort Worth and the Trinity episcopal church of Fort Worth, click here.

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Pole vault: Duplantis, so young and already so high

[Mise à jour : Duplantis a franchi les 6,18 m le samedi 15 février à Glasgow]

Renaud Lavillenie is no longer a record holder in the world of pole vault. The French athletics star, who had the best world performance of all time since February 2014, when he jumped 6.16 m in Donetsk under the eyes of former record holder Sergei Bubka, passes his hand to the star rising specialty: Armand Duplantis, 20 years old. The latter, although born and raised in the United States (in Lafayette, Louisiana), competes under the colors of Sweden, his mother’s country. Duplantis, nicknamed “Mondo” in the narrow circle of athletics, passed the 6.18m mark in Glasgow on Saturday. He had already crossed the 6.17 m barrier at the indoor meeting in Torun, Poland, a week earlier. The performance of the young man with “normal” physique – 68 kilos for 1.81 m – is not really a surprise. Tuesday, in a meeting in Germany, he attacked the Lavillenie record and failed by nothing.

In the garden of the house

Armand Duplantis presents the typical CV of the prodigy of his discipline, to which he was initiated by his father and coach since his earliest childhood. He indeed started to panic the counters of the specialty at 10 years old. The son of Greg Duplantis and Helena Hedlund, a former volleyball player and heptathlete, and now her fitness trainer, began his jumping career in the garden of the family home. At 10, he crossed 3.86m, the world record for this age category. Passionate about the specialty are beginning to scrutinize the gestures of the child acrobat on YouTube. The father himself is a former American pole vaulter, capable of jumping 5.80m from the top of his 1.68m. It is perhaps thanks to the size of his father that the son drew his greatest strength: technique. When you don’t have a Superman physique, you have to bet everything on it, essential on the acrobatic part and speed. Qualities probably worked to nausea by Greg Duplantis and his son.

Duplantis displays perfect mastery of the different parts of which a pole vault consists. For the average viewer, this very complex exercise may seem easy and almost natural: but it is the mark of the virtuoso to give this impression. From this point of view, Duplantis has a lot in common with Renaud Lavillenie, his young idol, with whom he shared a few jumping sessions and long discussions about their sport.

Provider, athlete, tightrope walker

Just watch his jumps, for example at the European Championships in Berlin in August 2018, where at just 18 years old (still a junior then), he won one of the most distinguished contests in the history of this championship. At an Olympic stadium in Berlin, during an interminable summer evening, Duplantis had to pull from his hat of conjurer-athlete-tightrope walker a jump to 6.05 m, while the final seemed to end at 5.95 m. This measurement represented at the time his personal best and also the junior world record. Second place was for the young Russian Timur Morgunov (6.00 m), meteor of the discipline, while the bronze medal went to an always combative Renaud Lavillenie at the beautiful altitude of 5.95 m, which in most old editions would have given right to the highest step of the podium.

At the world championships in Doha, at the beginning of October 2019, Duplantis wins “only” the money behind another ace in the discipline, the American Sam Kendricks, in a competition not frankly high-flying: 5.97 m for Kendricks and Duplantis , the American winning the number of tries at 5.92 m. In Qatar, the Swede had appeared a bit sprained, perhaps because of the string of meetings which had made up his season. Saturday in Torun, on the second attempt at 6.17 m, Duplantis agreed with all of their opponents: he is now the boss of the discipline.

Luca Endrizzi

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