Search Results for “FDA” – Page 57 – media

New drug formulation for opioid addiction approved by FDA.

Cassipa, a Teva Phaarmaceuticals manufactured sublingual film containing naloxone and buprenorphine in new dosage amounts, receives FDA approval on the 7th of September as a continuing therapy for opioid addiction. In a press release, the FDA announced that the buprenorphine and naloxone sublingual film, formulated in a 16 mg/4 mg dose for Cassipa, is sanctioned not only in its brand version but also in its generic edition. The two drugs in different strength combinations are also approved by the FDA. A set management protocol including psychotherapy and counseling should comprise of Cassipa post the patient is administered and stabilized with a step-ladder buprenorphine 16 mg dose of another brand. Drug Addiction Treatment Act (DATA) certified professionals only can prescribe these drugs. “There’s an urgent need to ensure access to, and wider use and understanding of, medication-assisted treatment for opioid use disorder … the FDA recently described a streamlined approach to ...
- Source: drugdu
- 1,193
- September 11, 2018
FDA Approved Eye Drop Oxervate to Treat Neurotrophic Keratitis

Neurotrophic Keratitis (NK) is a rare eye disorder that affects the corneal sensation leading to a loss in vision. Till date, only invasive surgeries and palliative treatments were available to treat the disease. But now, there is a major breakthrough in this regard since the US-FDA has approved the Italian company Dompé’s eye drop, Oxervate in order to treat NK.
- Source: FiercePharma
- 1,305
- August 27, 2018
FDA New Approvals rare eye disease
First Dual-Lead Nerve Stimulator for Pain Management gets FDA Nod

SPR Therapeutics’ single- and dual-lead peripheral nerve stimulation devices win FDA nod as minimally invasive, non-opioid alternatives to treat acute chronic, postoperative and post-traumatic pain when implanted for up to two months.
- Source: FiercePharma
- 1,286
- August 22, 2018
FDA medical device New Approvals
FDA Grants Approval for Brainsway’s OCD-Treating TMS System

Obsessive-compulsive disorder (OCD) patients are now offered with a new treatment option as the FDA grants de novo approval for Brainsway’s deep transcranial magnetic stimulation (TMS) system.
- Source: Mass Device
- 1,082
- August 22, 2018
FDA medtech Mental health New Approvals
Xolair Gets FDA Approval for Food Allergy Treatment

Xolair of Novartis and Roche has been declared as a breakthrough therapy for food allergies including eggs, milk and peanuts by the Food and Drugs Administration (FDA).
- Source: FiercePharma
- 977
- August 15, 2018
FDA food allergies New Approvals
De-Novo Marketing FDA Approval for Natural Cycles’ Contraception App

The US-FDA (US- Food and Drugs Administration) announced on 13 August that it will permit the marketing of Natural Cycles’ contraception app in the US for pre-menopausal women aged 18 years and older.
- Source: MobiHealthNews
- 1,096
- August 14, 2018
contraception FDA New Approvals
Contraceptive Vaginal Ring; Annovera granted FDA Approval

Annovera (segesterone acetate and ethinyl estradiol vaginal system), a multi-use donut-shaped ring, was recently approved and presented to the Population Council by the FDA.
- Source: MDEdge
- 1,008
- August 13, 2018
contraception FDA New Approvals
Alembic Pharma gets USFDA Approval for Ophthalmic Solution

Hypotrichosis is defined as the condition of abnormal hair patterns which leads to predominant loss or reduction. Usually, hair growth is normal after birth, but later, hair starts shedding and is replaced by abnormal hair growth patterns. The new hair will be short and brittle without pigmentation.
- Source: MoneyControl
- 806
- August 8, 2018
FDA Hypotrichosis New Approvals
Axiostat Becomes the First US FDA-Approved Wound Dressing Product from India

Axiostat, the first US Food and Drug Administration (USFDA) approved wound dressing product from India is a user-friendly, compact pack of 8X8 centimeters which ceases unrestrained bleeding from wounds. When applied on a wound, the patch acts on the blood and forms a clot in a minute and turns into a very sticky adhesive patch.
- Source: BusinessToday
- 844
- August 3, 2018
India medtech New Approvals Wound healing
Adherium Receives FDA Clearance for Hailie Inhaler Sensor

Adherium, the makers of inhaler sensors, has received 510(k) US-FDA clearance for the sales of its Hailie sensor, previously known as Smartinhaler. The individual versions of this device were previously cleared for use with the asthma inhalers like Ventolin HFA, ProAir HFA, and Flovent HFA.
- Source: MobiHealthNews
- 1,238
- August 1, 2018
asthma FDA New Approvals

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