February 2012 FDA approved new drug profile

In February 2012, the FDA approved one NME drug and four new drug formulations. The new molecular entity (NME) drug is Merck's ophthalmic drug, tafluprost. The new formulations of drugs are Balsalazine tablets, mitomycin C topical solution, sitagliptin / metformin compound sustained-release tablets, ivermectin topical lotion.

Table: February 2012 FDA Approved New Drug Trade Name Generic Name (Chinese) Company Specifications Dose Approval Type Approval Date GIAZO BALSALAZIDE DISODIUM SALIX PHARMS 1.1G Tablet New Formulation February 3 MITOSOL MITOMYCIN (Missed (Doxamicin) MOBIUS THERAPEUTICS 0.2MG topical solution new formulation February 7 JANUMET XR SITAGLIPTIN; METFORMIN HYDROCHLORIDE (Sitagliptin/Metformin) MERCK SHARP DOHME (MSD) 50MG; 500MG/50MG; 1000MG/100MG; 1000MG sustained release tablets new Dosage Form February 2 ZIOPTAN TAFLUPROST (Talfluoro Prostaglandin) MERCK SHARP DOHME (Mercton) 0.00% Eye Drop New Molecular Entities (NME) February 10 SKLICE IVERMECTIN (Ivermectin) SANOFI-TOPAZ INC (Sanofi ) 0.50% lotion; external use of new formulations on February 7 GIAZO (Baliudis disodium), SALIX company production, specifications 1.1G, dosage forms for tablets. The drug was previously approved by the FDA as a capsule.

MITOSOL, MOBIUS THERAPEUTICS product, is a newly approved formulation for topical use for glaucoma surgery. MITOSOL can accurately provide mitomycin C doses to help smooth glaucoma surgery. Previous mitomycin formulations are injections.

JANUMET XR (Sitagliptin/Metformin), a drug company for the treatment of diabetes mellitus, is a newly approved sustained-release tablet that allows patients to take the drug once a day. There are 3 specifications for this approval. In the past, sitagliptin/metformin was a common oral tablet dosage form.

ZIOPTAN (Teflon Prostaglandin), produced by Merck & Co., is a new molecular entity (NME) drug. It is the first preservative-free prostaglandin-based ophthalmic solution used in open-angle glaucoma or ocular hypertension patients to reduce intraocular pressure. (For more information, click on the Mino data - China Prostaglandin Eye Drops Market Overview)

SKLICE (Ivermectin), produced by Sanofi, is a new lotion for topical lotion. Previous FDA approved formulations were oral tablets. This product is used for topical treatment of tinea capitis patients aged ≥6 months. (Researcher Wu Junjie)