Category «FDA 2016»

Lifitegrast

It’s only fair to share… 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 …

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

It’s only fair to share… 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 …

FDA approves Eucrisa (crisaborole) for eczema

It’s only fair to share… News Release FDA approves Eucrisa for eczema The U.S. Food and Drug Administration today approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older. Read more. For Immediate Release December 14, 2016 Release The U.S. Food and Drug Administration today …

ZINPLAVA (BEZLOTOXUMAB), Approved FDA

It’s only fair to share… BEZLOTOXUMAB Biologic License Application (BLA): 761046 Company: MERCK SHARP DOHME Drug Name(s): • ZINPLAVA (BEZLOTOXUMAB) http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761046s000lbl.pdf http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761046Orig1s000ltr.pdf Drug Name Active Ingredient Approval Date FDA-approved use on approval date Zinplava bezlotoxumab 10/21/2016 To reduce the recurrence of Clostridium difficile infection in patients aged 18 years or older Drug Trials Snapshot From Wikipedia, …

FDA approves Intrarosa for postmenopausal women experiencing pain during sex

It’s only fair to share… FDA approves Intrarosa for postmenopausal women experiencing pain during sex The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing …

US FDA grants approval for Novartis’ Ilaris (canakinumab) to treat Periodic Fever Syndromes

It’s only fair to share… Ribbon diagram of canakinumab (blue) bound to IL-1β (yellow) from PDBentry 5bvp[1] US FDA grants approval for Novartis’ Ilaris to treat Periodic Fever Syndromes Novartis has received the US Food and Drug Administration’s (FDA) approval for Ilaris (canakinumab) to treat rare Periodic Fever Syndrome conditions. 26 September 2016 Read at http://www.pharmaceutical-technology.com/news/newsus-fda-grants-approval-for-novartis-ilaris-to-treat-periodic-fever-syndromes-5014453?WT.mc_id=DN_News …

FDA approves Amjevita, a biosimilar to Humira

It’s only fair to share… 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 …

Pimavanserin

It’s only fair to share… 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) …

FDA grants accelerated approval to first drug for Duchenne muscular dystrophy

It’s only fair to share… CAS 1173755-55-9 eteplirsen, eteplirsén [Spanish], étéplirsen [French] , eteplirsenum [Latin], этеплирсен [Russian], إيتيبليرسان [Arabic] Structure credit http://lgmpharma.com/eteplirsen-still-proves-efficacious-duchenne-drug/ FDA grants accelerated approval to first drug for Duchenne muscular dystrophy New therapy addresses unmet medical need The U.S. Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy …