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FDA Approves Pediatric Infection Treatment
Teflaro treats acute bacterial skin and skin structure infections, and community-acquired bacterial pneumonia (CABP).
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Teflaro Approved for Pediatric Patients
Pediatric patients may now use ceftaroline fosamil (Teflaro) as a treatment for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia.
Label Change Sought for Veltassa in Hyperkalemia Treatment
Relypsa is hoping to change its label for patiromer (Veltassa) for oral suspension in hyperkalemia treatment.
FDA Approves Agent that Detects Recurrent Prostate Cancer
Fluciclovine F 18 is a radioactive diagnostic agent for injection that can be used to detect recurring prostate cancer.
FDA Approves New Agent to Detect Recurrent Prostate Cancer
Fluciclovine F 18 (Axumin) is a radioactive diagnostic agent that can be used to detect recurring prostate cancer.
New Agent Approved to Detect Recurrent Prostate Cancer
The FDA has approved fluciclovine F 18 (Axumin), which is a radioactive diagnostic agent for injection that can be used to detect recurring prostate cancer.
Generic Zomig and Vfend Launched by Ajanta Pharma
Ajanta Pharma Limited has been given final approval from the FDA to launch zolmitriptan tablets, 2.5 mg and 5 mg, and voriconazole tablets, 50 mg and 200 mg.
Relypsa Seeks to Change Veltassa Label
Relypsa is hoping to change its label for patiromer (Veltassa) for oral suspension based on the results of 12 phase 1 drug-drug interaction studies.
FDA Approves Generic Fenofibrate Launch
Generic drug treats patients who have a high cholesterol and triglyceride in their blood.
Aurobindo Given OK for Generic TriCor Launch
Aurobindo Pharma Limited has received final approval from the FDA to launch fenofibrate tablets, 48 mg and 145 mg.
Advanced Renal Cell Carcinoma Treatment Approved
The FDA has approved Eisai's lenvatinib (Lenvima) for the treatment of advanced renal cell carcinoma in combination with everolimus after prior antiangiogenic therapy.
Dietary Supplements Recalled Due to Presence of Sildenafil
SOS Telecom Inc is voluntarily recalling dietary supplements that contain sildenafil.
Generic Migraine Medication Launched
Frovatriptan succinate tablets, the generic equivalent to Frova tablets, is administered for acute migraine headache treatment in adults.
Generic Frova Launched
Mylan has launched frovatriptan succinate tablets, 2.5 mg, which are the generic equivalent to Endo's Frova tablets.
FDA Approves Actinic Keratosis Therapy
Ameluz is used for photodynamic therapy treatment of mild to moderate actinic keratosis on the face and scalp.
Actinic Keratosis Treatment Approved
The FDA has approved Biofrontera's topical prescription drug BF-200 ALA (Ameluz) and medical device BF-RhodoLED.
FDA Approves New Hypotension Treatment
Ephedrine sulfate (Akovaz) is a drug administered parenterally to address hypotension in surgical settings.
New Hypotension Treatment Approved
The FDA has approved Flamel Technologies' new drug application for ephedrine sulfate (Akovaz), which is a drug administered parenterally to address hypotension in surgical settings.
Compounding Pharmacy Asked by FDA to Recall Products
FDA recommends health care facilities quarantine products from Medaus Inc that are intended to be sterile.
FDA Requests Compounding Pharmacy Recall Products
The FDA is warning health care professionals and patients about products intended to be sterile that were compounded by Medaus Inc.
FDA Bans Pharmacy Owner from Compounding Sterile Drugs
Paul W. Franck allegedly manufactured and distributed products that violated the Federal Food, Drug, and Cosmetic Act.
FDA Prohibits Paul W. Franck from Compounding Sterile Drugs
The FDA has entered a permanent injunction against Paul W. Franck, who allegedly manufactured and distributed products that violated the Federal Food, Drug, and Cosmetic Act.
FDA Approves First Generic Version of Crestor
Crestor treats hypertriglyceridemia and homozygous familiar hypercholesterolemia, either alone or in combination with other cholesterol treatments.
First Generic Version of Crestor Approved
The FDA has approved the first generic version of rosuvastatin calcium (Crestor) tablets.
FDA Grants Emergency Use Authorization for Zika Test
Quest Diagnostics has received emergency use authorization from the FDA for the Zika Virus RNA Qualitative Real-Time RT-PCR test.
Treatment for Parkinson's Disease Psychosis Approved
The FDA has approved Acadia Pharmaceuticals' pimavanserin (Nuplazid), the first drug that can help treat hallucinations and delusions associated with psychosis experienced by some patients with Parkinson's disease.
Glass Particles Lead to Recall of Sensorcaine-MPF Injection
Fresenius Kabi USA is voluntarily recalling a single lot of bupivacaine HCI (Sensorcaine-MPF) injection due to the presence of glass particulate matter.
Study Linking Diflucan with Higher Risk of Miscarriage Under FDA Review
The FDA is reviewing the results of a Danish study that found the oral use of fluconazole (Diflucan) for yeast infections may increase the risk of miscarriage.
Abuse-Deterrent Xtampza ER Approved
The FDA has approved Collegium Pharmaceutical Inc's oxycodone extended-release capsules (Xtampza ER) for severe pain.
COPD Maintenance Treatment Gets FDA Approval
Bevespi Aerosphere is a twice-daily, fixed-dose dual bronchodilator combining a long-acting muscarcinic antagonist and a long-acting beta-2 agonist.