January 2012 FDA approved new drug profile

It was learned from the FDA website that in January 2012, one new drug for biological agents, three drugs for new molecular entities (NME), and three drugs for new formulations were approved. Involves Pfizer, Genentech, GILEAD and many other pharmaceutical companies.


Voraxaze is used in patients with delayed methotrexate clearance to reduce their in vivo toxic plasma methotrexate concentrations, which can be caused by impaired renal function in patients. The product is a biological agent.

VIREAD is a GILEAD product for the treatment of AIDS. The original dosage form was tablet. In 2012, the newly approved dosage form was oral powder, suitable for children aged 2 to 12 years. VIREAD uses a special container to quantitatively mix medicine with food to facilitate swallowing.

Zetonna Nasal Aerosol Spray is used for the symptomatic treatment of seasonal and perennial allergic rhinitis in adults and teenagers over the age of 12 years. Ciclesonide is a corticosteroid, and the original dosage form is a hand-pump spray metered dose inhaler.

PICATO gels are approved for the treatment of actinic keratoses, which are precancerous lesions caused by cumulative sun exposure and may progress to squamous cell carcinoma.

BYDUREON (exenatide), commonly known as BYETTA in English, was approved by the FDA in 2012 for the release of sustained-release formulations once a week for the treatment of type 2 diabetes. Studies have shown that at 24 weeks of treatment, exenatide slow-release dosage forms can reduce 1.6% of glycated hemoglobin compared to baseline, while the dosage form twice daily decreases by 0.9%. The most common adverse reactions to the drug are nausea, hypoglycemia, vomiting, diarrhea, nervousness, dizziness, headache, indigestion, constipation, and weakness.

INLYTA (Axitinib) Pfizer products for the treatment of advanced kidney cancer (renal cell carcinoma) that do not respond to other drugs. INLYTA is a small molecule tyrosine kinase inhibitor that is active against multiple targets, including VEGF receptors 1, 2 and 3. The most common adverse reactions included diarrhea, high blood pressure, fatigue, loss of appetite, and nausea. The FDA said that hypertensive patients should control blood pressure before receiving axitinib.

ERIVEDGE is produced by Genentech and is used for the treatment of basal cell carcinoma (BCC). It is suitable for advanced cancer patients who cannot perform surgery or chemotherapy, and patients whose cancer cells have spread to other body organs. The patient takes it once a day. The label on the ERIVEDGE pill warns that if this drug is used for pregnant women it may cause the baby to die. Its most common side effects include muscle cramps, hair loss, weight loss, diarrhea, fatigue, altered or loss of taste, loss of appetite, constipation, and vomiting.

KALYDECO is used to treat cystic fibrosis (CF). Take 1 tablet every 12 hours. Patients with moderate and severe hepatic insufficiency have correspondingly reduced doses. When combined with a moderate or strong inhibitor of CYP3A, reduce the dose. (Researcher Wu Junjie)