Tag «FDA 2016»

Talazoparib, MDV3800

Talazoparib, BMN-673, MDV-3800 (2S,3S)-methyl-7-fluoro-2-(4-fluorophenyl)-3-(1-methyl-1H-1,2,4-triazol-5-yl)-4-oxo-1,2,3,4-tetrahydroquinoline-5-carboxylate (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one CAS 1207456-01-6 Chemical Formula: C19H14F2N6O Exact Mass: 380.11972 BMN673, BMN673, BMN-673, LT673, LT 673, LT-673, Talazoparib BioMarin Pharmaceutical Inc phase 3 Poly ADP ribose polymerase 2 inhibitor; Poly ADP ribose polymerase 1 inhibitor cancer (85,9R)-5-fluoro-8-(4-fluorophenyl)-9-(l-methyl-lH-l,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one toluenesulfonate salt CAS 1373431-65-2(Talazoparib Tosylate) 1H NMR DMSOD6 13C NMR DMSOD6 HMBC NMR HSQC NMR Talazoparib (BMN-673) …

Lifitegrast

Lifitegrast, SAR 1118 SAR-1118-023 CAS 1025967-78-5 Xiidra (lifitegrast ophthalmic solution) FDA approves new medication for dry eye disease 07/12/2016 08:48 AM EDT The U.S. Food and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease, on Monday, July 11, 2016. Xiidra is the first medication in …

FDA approves first drug Spinraza (nusinersen), for spinal muscular atrophy

FDA approves first drug for spinal muscular atrophy New therapy addresses unmet medical need for rare disease The U.S. Food and Drug Administration today approved Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement. Spinraza is …

FDA grants accelerated approval to new treatment for advanced ovarian cancer , Rubraca(rucaparib)

The U.S. Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. Rubraca is approved for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an …

FDA approves Amjevita, a biosimilar to Humira

FDA approves Amjevita, a biosimilar to Humira The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar toHumira (adalimumab) for multiple inflammatory diseases. Read more. FDA approves Amjevita, a biosimilar to Humira For Immediate Release September 23, 2016 Release The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar …

Pimavanserin

Pimavanserin MF C25H34FN3O2 MW 427.555 Pimavanserin, ACP 103, ACP-103; BVF-048 N-(4-fluorophenylmethyl)-N-(1-methylpiperidin-4-yl)-N’-(4-(2-methylpropyloxy)phenylmethyl)carbamide, 706779-91-1 (Pimavanserin ) 706782-28-7 (Pimavanserin Tartrate) for treatment of psychotic symptoms in patients with Parkinson’s disease WATCH OUT AS THIS POST IS UPDATED……….. Trade Name：Nuplazid® MOA：5-HT2A inverse agonist Indication：Hallucinations and delusions associated with Parkinson’s disease psychosis Company：Acadia (Originator) APPROVED US FDA 2016-04-29, ACADIA PHARMS INC, (NDA) 207318 To treat hallucinations and …