Instruct: Given a question, retrieve relevant passages that answer the question.
Query: What was the first drug approved by the FDA to treat depression?
The SSRIs are the first rationally designed class of psychotropic medications. The strategy behind rational drug design is to develop a new drug that is capable of affecting a specific biological target, or in this case a special neural site of action (uptake pumps, receptors), while trying to avoid effects on other site of actions. The goal in such development is to produce pharmacological agents that are more efficacious, safer and better tolerated than older medications.[8] An initial success was achieved when medicinal chemists set out in search of the ideal SSRI with the chemical synthesis of zimelidine (figure 1) from the antihistamine drug brompheniramine,[7] which exhibited selective inhibition of 5-HT re-uptake with minimal inhibition of norepinephrine (NE) re-uptake. Most importantly, zimelidine did not come with the adverse effect profile as the TCAs and therefore it became the template for the second generation SSRIs.[5] Zimelidine was the first SSRI to be marketed, but several cases of Guillain–Barré syndrome were associated with the use of the drug which led to withdrawal from the market in 1983. Subsequently, several non-tricyclic SSRIs were discovered and marketed. Fluoxetine, which was FDA approved in 1987 and is usually thought to be the first SSRI to be marketed, paved the way for the next generation of SSRIs and was thought to be some kind of prototype.[5] Introduction of fluoxetine to the market is hailed as a miracle drug for the treatment of depression because it had fewer adverse effects, simpler dosing strategies and greater margin of safety when overdoses were consumed and thus it had better adherence, compared to the older antidepressants (TCAs and MAOIs).[5][9] Since then the number of drugs in the SSRI class has become bigger and they are now six (fluoxetine, paroxetine, citalopram, escitalopram, sertraline and fluvoxamine),[4][8] as demonstrated in table 1.
Neurocrine announced it filed a new drug application (NDA) for its once-daily valbenazine drug treating TD on August 29, 2016. Valbenazine received a priority review designation, fast track status and a breakthrough designation from the FDA. In April 2017, the FDA approved INGREZZA (valbenazine) for the treatment of TD. At the time of approval, it was the first and only drug approved for adults with TD. Neurocrine is also studying valbenazine in clinical trials for the treatment of Tourette Syndrome. In October 2017, Neurocrine announced that it had been granted orphan drug designation status from the FDA for valbenazine for the treatment of pediatric patients with Tourette syndrome.
Dietary supplements do not have to be approved by the U.S. Food and Drug Administration (FDA) before marketing, but companies must register their manufacturing facilities with the FDA and follow current good manufacturing practices (cGMPs). With a few well-defined exceptions, dietary supplements may only be marketed to support the structure or function of the body, and may not claim to treat a disease or condition, and must include a label that says: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” The exceptions are when the FDA has reviewed and approved a health claim. In those situations the FDA also stipulates the exact wording allowed.
Larotrectinib was the first drug to be specifically developed and approved to treat "any" cancer containing certain mutations, as opposed to cancers of specific tissues (i.e., the approval is "tissue agnostic"). Several earlier drugs, including pembrolizumab, were eventually approved by the FDA for treatment of specific mutations independent of the type of cancer, but those drugs had been initially developed for specific cancer types.
Arsanilic acid gained use as a feed additive for poultry and swine to promote growth and prevent or treat dysentery. For poultry and swine, arsanilic acid was among four arsenical veterinary drugs, along with carbarsone, nitarsone, roxarsone, approved by the U.S. Food and Drug Administration (FDA). In 2013, the FDA denied petitions by the Center for Food Safety and by the Institute for Agriculture and Trade Policy seeking revocation of approvals of the arsenical animal drugs, but the drugs' sponsors voluntarily requested the FDA to withdraw approvals of three, including arsanilic acid, leaving only nitarsone approved. In 2015, the FDA withdrew nitarsone's approval. Arsanilic acid is still used in the laboratory, for instance in recent modification of nanoparticles.
Despite the company's success on the diagnostic front, Schoemaker was plunged in 1992 into efforts to save the company from bankruptcy when its first therapeutic, Centoxin, a drug designed to treat septic shock, failed to win FDA approval. In part the crisis had come about as a result of the Company's executives trying to go it alone in developing the drug. What saved the company was a return to the policy of collaboration. Learning from its mistakes with Centoxin, in December 1994 Centocor gained marketing approval for ReoPro, a monoclonal antibody drug for cardiovascular disease. The first therapeutic to ever receive simultaneous US and European approvals, and the second monoclonal antibody to ever win approval as a drug, ReoPro marked a milestone for both Centocor and for monoclonal antibodies therapeutics. ReoPro was to be followed in August 1998 by the approval of Centocor's Remicade, a drug to treat auto-immune disorders like Crohn's disease and rheumatoid arthritis.
A variety of medical devices are in use or under consideration for treatment of depression including devices which offer electroconvulsive therapy, vagus nerve stimulation, repetitive transcranial magnetic stimulation, and cranial electrotherapy stimulation. Use of such devices in the United States requires approval by the U.S. Food and Drug Administration (FDA) after field trials. In 2010 a FDA advisory panel considered the question of how such field trials should be managed. Factors considered were whether drugs had been effective, how many different drugs had been tried, and what tolerance for suicides should be in field trials.
Collagenase clostridium histolyticum (Auxilium), a drug originally approved by the FDA to treat Dupuytren's contracture, is now an FDA-approved injectable drug for treatment of Peyronie's disease. The drug is reported to work by breaking down the excess collagen in the penis that causes Peyronie's disease.
In the United States, concerns about a possible manufacturing error or tampering were lost amid a media outcry about the "illegal" use of "illegal" drugs not approved by the FDA, even "banned" by the FDA. In the US, Biodyl is neither an illegal drug nor a banned drug, but it is an unapproved drug. Although Biodyl is a dietary supplement, a type of product that normally is not subject to FDA approval, FDA approval is required to market injectable solutions (except animal vaccines, which are subject to USDA approval). An Associated Press story misreported an October 2008 FDA refusal to permit commercial importation of the solution as a refusal to approve the solution. In fact, Biodyl is not FDA-approved because the manufacturer has never submitted an application for FDA approval. Also, the FDA may permit the importation of unapproved drugs for personal use for pets.
Terazosin was the first long lasting alpha 1 blocker approved by FDA to treat BPH. Doxazosin and Tamsulosin was approved after. The first line treatment choice today to treat BPH is tamsulosin. It is not because it is better tolerated or had greater efficacy than the previous drugs. Only because of the minimal dose titration. Alfuzosin SR (sustained release) was the fourth alpha 1 selective blocker to be approved by FDA. It is used to treat BPH and the good thing about Alfuzosin SR is, it doesn't need a dose titration. Over 30 years of improving alpha 1 blockers for BPH it has been primarily focused on tolerance and good use.
In 1988, Peterson was the first physician to treat an extremely ill person diagnosed with CFS with the experimental drug Ampligen by obtaining compassionate-use permission from the U.S. Food and Drug Administration. Quantitative improvement in the first patient enabled the next pilot study of Ampligen in CFS patients by Peterson and other researchers. During the 1990 CFIDS Conference in Charlotte, North Carolina, Peterson described positive results in 15 CFS patents after he treated them with Ampligen for approximately 6 months. In 1990 and 1991, Peterson was one of four principal investigators for the FDA approved phase II randomized placebo controlled double-blind study of the experimental intravenous drug Ampligen. The drug was administered in his Incline Village facility and three other sites. Peterson and others reported that there was statistically significant improvement in the patients receiving Ampligen. He is a principal investigator of the FDA-approved open-label safety and efficacy phase III drug study of Ampligen for treatment of chronic fatigue syndrome. Hemispherx Biopharma's New Drug Application for marketing and sale of Ampligen to treat chronic fatigue syndrome was rejected in December 2009 because the FDA concluded that the two RCTs "did not provide credible evidence of efficacy."
ALKS-5461 was granted Fast Track Designation by the Food and Drug Administration (FDA) for treatment-resistant depression in October 2013. During June and July 2014, three phase III clinical trials were initiated in the United States for treatment-resistant depression. Alkermes reported that the first two trials failed in 2016. In August 2017, based on the third trial, Alkermes announced the initiation of a rolling submission of a New Drug Application for ALKS-5461 to the FDA. On 31 January 2018, Alkermes submitted a New Drug Application for ALKS-5461 to the FDA for the adjunctive treatment of major depressive disorder. The submission was accepted by the FDA on 9 April 2018 after initially serving a refuse-to-file letter due to insufficient evidence of overall effectiveness. In November 2018, an FDA advisory committee voted overwhelmingly against recommending approval, finding that evidence of efficacy was insufficient.
Fluvoxamine was developed by Kali-Duphar, part of Solvay Pharmaceuticals, Belgium, now Abbott Laboratories, and introduced as Floxyfral in Switzerland and Solvay in West Germany in 1983. It was approved by the FDA on 5 December 1994 and introduced as Luvox in the US. In India, it is available, among several other brands, as Uvox by Abbott. It was one of the first SSRI antidepressants to be launched, and is prescribed in many countries to patients with major depression. It was the first SSRI, a non-TCA drug, approved by the U.S. FDA specifically for the treatment of OCD. At the end of 1995, more than ten million patients worldwide had been treated with fluvoxamine. Fluvoxamine was the first SSRI to be registered for the treatment of obsessive compulsive disorder in children by the FDA in 1997. In Japan, fluvoxamine was the first SSRI to be approved for the treatment of depression in 1999 and was later in 2005 the first drug to be approved for the treatment of social anxiety disorder. Fluvoxamine was the first SSRI approved for clinical use in the United Kingdom.
It is the first small interfering RNA-based drug approved by the FDA and the first drug approved by the FDA to treat this condition. It is a gene silencing drug that interferes with the production of an abnormal form of transthyretin. 
After four whistleblowers initially filed suits under the False Claims Act, prompting a government investigation, Eli Lilly and Company agreed to plead guilty and pay $1.415 billion for promoting its drug Zyprexa for uses not approved by the FDA. Specifically, the private whistleblower complaints and the government alleged that Eli Lilly engaged in a marketing scheme over a period of several years to promote the drug's use in children and the elderly, groups particularly vulnerable to the product's side effects. An antipsychotic drug initially approved in 2000 to treat manifestations of certain psychotic disorders, the government's indictment contended that Eli Lilly deliberately marketed the drug to treat agitation, aggression, hostility, dementia, Alzheimer’s dementia, depression and generalized sleep disorder, none of which were uses approved by the FDA.
Additionally, the FDA states that: "Food, Drug and Cosmetic Act defines drugs as those products that cure, treat, mitigate or prevent disease or that affect the structure or function of the human body. While drugs are subject to an intensive review and approval process by FDA, cosmetics are not approved by FDA prior to sale. If a product has drug properties, it must be approved as a drug."
In 2017, August 29 the U.S. Food and Drug Administration (FDA) approved Chemo Research’s New Drug Application (NDA) for benznidazole 567891011 . This is the first drug ever approved by the FDA to treat Chagas disease. The FDA’s decision approves benznidazole for children ages 2–12 years old 12. Mundo Sano played a central role in registering benznidazole with the U.S. Food and Drug Administration (FDA), in close collaboration with Exeltis (Chemo US-based pharmaceutical division), with the support of the Drugs for Neglected Diseases initiative (DNDi), a non-profit drug development organization.
A "qui tam" suit filed under the False Claims Act led AstraZeneca to make a massive $520 million settlement to resolve all civil and criminal liability with respect to illegal promotion of the anti-psychotic drug Seroquel. Approved by the FDA in 1997 to treat manifestations of psychotic disorders, in 2000 the FDA subsequently approved Seroquel for short-term treatment of schizophrenia, bipolar disorder, and bipolar depression. Between January 2001 through December 2006, AstraZeneca promoted Seroquel to psychiatrists and other physicians for certain uses that were not approved by the FDA, including aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness. Federal health programs do not reimburse for prescriptions prescribed for indications not approved by the FDA.
Olanzapine/fluoxetine was approved by the U.S. Food and Drug Administration (FDA) to treat the depressive episodes of bipolar I disorder in 2003. In 2009, it was granted approval for the treatment of treatment-resistant depression.
Ivacaftor was developed by Vertex Pharmaceuticals in conjunction with the Cystic Fibrosis Foundation and is the first drug that treats the underlying cause rather than the symptoms of the disease. It was approved by the FDA in January 2012. It is one of the most expensive drugs, costing over US$300,000 per year, which has led to criticism of the high cost. The combination drug was approved by the FDA in July 2015.
Allopregnanolone has been under development by Sage Therapeutics as an intravenously administered drug for the treatment of super-refractory status epilepticus, postpartum depression, and essential tremor. A date of 19 March 2019 has been set by the FDA for approval of allopregnanolone for postpartum depression (i.e., the FDA will review and possibly approve allopregnanolone by this deadline).
The Food and Drug Administration (FDA) approved in January 2014 the melatonin agonist Hetlioz (tasimelteon) for the treatment of non-24 for blind people. This is the first FDA-approved drug for any circadian rhythm sleep-wake disorder, since melatonin is unregulated. Tasimelteon safely and effectively treated non-24 patients with an entrainment rate of 20%, which is lower than melatonin with 67%.
In November 2016, the new drug application was accepted under the FDA's priority review process on the strength of the Phase III trial and the unmet need, and was also accepted for review at the European Medicines Agency (EMA) at that time. It was approved by the FDA in December 2016 and by EMA in May 2017 as the first drug to treat spinal muscular atrophy. Subsequently, nusinersen was approved to treat SMA in Canada (July 2017), Japan (July 2017), Brasil (August 2017) and Switzerland (September 2017).
Clomipramine was developed by Geigy. It was first referenced in the literature in 1961 and was patented in 1963. The drug was first approved for medical use in Europe in the treatment of depression in 1970, and was the last of the major TCAs to be marketed. In fact, clomipramine was initially considered to be a "me-too drug" by the FDA, and in relation to this, was declined licensing for depression in the United States. As such, to this day, clomipramine remains the only TCA that is available in the United States that is not approved for the treatment of depression, in spite of the fact that it is a highly effective antidepressant. Clomipramine was eventually approved in the United States for the treatment of OCD in 1989 and became available in 1990. It was the first drug to be investigated and found effective in the treatment of OCD. The first reports of benefits in OCD were in 1967, and the first double-blind, placebo-controlled clinical trial of clomipramine for OCD was conducted in 1976, with more rigorous clinical studies that solidified its effectiveness conducted in the 1980s. It remained the "gold standard" for the treatment of OCD for many years until the introduction of the SSRIs, which have since largely superseded it due to greatly improved tolerability and safety (although notably not effectiveness). Clomipramine is the only TCA that has been shown to be effective in the treatment of OCD and that is approved by the FDA for the treatment of OCD; the other TCAs failed clinical trials for this indication, likely due to insufficient serotonergic activity.
Dalbavancin (once-weekly injection) was undergoing a phase II trial, due to end in 2003. The FDA approved Dalbavancin for use to treat MRSA infections in adults on May 23, 2014. Dalbavancin (Dalvance) is intended to treat acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like "Staphylococcus aureus" (including methicillin-susceptible and methicillin-resistant strains) and "Streptococcus pyogenes". Dalbavancin is the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, dalbavancin was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections. As part of its QIDP designation, dalbavancin was given priority review, which provides an expedited review of the drug’s application. dalbavancin's QIDP designation also qualifies it for an additional five years of marketing exclusivity to be added to certain exclusivity periods already provided by the Food, Drug and Cosmetic Act.