USFDA nod to Teva generic nasal spray-Narcan to treat opioid overdose Medical Dialogues Bureau21 April 2019 3:57 AM GMTThe U.S. Food and Drug Administration granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a...
Setback: USFDA rejects Sanofi, Lexicon Sotagliflozin for type 1 diabetes Farhat Nasim24 March 2019 4:15 AM GMTThe decision comes about two months after an FDA advisory panel failed to reach a consensus over whether the once-daily oral drug, sotagliflozin, shoul...
USFDA puts partial hold on Abbvie Venclexta clinical trials after deaths Farhat Nasim21 March 2019 4:15 AM GMTThe clinical hold does not impact any of the approved indications for Venclexta, such as chronic lymphocytic leukaemia (CLL) or acute myeloid leukaemia...
USFDA accepts Allergan license applications to expand Botox label Farhat Nasim11 March 2019 4:00 AM GMT'The FDA's acceptance of Allergan's supplemental biologics license applications is a monumental milestone on our journey to bring new treatment options...
J&J passes asbestos test, allowed to make baby powder in India Farhat Nasim1 March 2019 8:58 AM GMTNEW DELHI: In a major relief to Johnson & Johnson(J&J), no asbestos was found in the baby powder manufactured in Baddi and Mulund plants. The...
Lupin gets USFDA nod to Methylprednisolone tablets to treat inflammation Farhat Nasim26 Feb 2019 4:20 AM GMTThe company has received approval from the US Food and Drug Administration (USFDA) to market Methylprednisolone tablets, a generic version of Pharmacia...
Mylan launches Advair generic at 70 percent discount in US Farhat Nasim14 Feb 2019 3:45 AM GMTThe treatment, the first generic of Advair, is approved in three doses and will be priced between $93.71 and $153.14, the company said.U.S: Mylan NV...
Pfizer says USFDA accepts regulatory submissions for review of tafamidis Medical Dialogues Bureau16 Jan 2019 4:05 AM GMTPfizer has submitted two NDAs based on two forms of tafamidis: meglumine salt and free acid. Tafamidis is the only product to complete a Phase 3 trial ...
Health Canada places restrictions on Allergan Fibroid treatment Esmya Farhat Nasim13 Jan 2019 3:30 AM GMTThe drug is sold in Europe by Hungarian drugmaker Richter. Richter has said it considered Esmya to be a safe and effective form of treatment.Canada:...
Lupin gets USFDA nod for generic schizophrenia drug Medical Dialogues Bureau8 Jan 2019 6:40 AM GMTNew Delhi: Drug maker Lupin Monday said it has received approval from the US health regulator to market Lurasidone Hydrochloride tablets, used in the...
Lupin receives FDA approval for Lurasidone Hydrochloride Tablets Farhat Nasim7 Jan 2019 4:15 AM GMTLupin's Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg & 120 mg is the generic version of Sunovion Pharmaceuticals, Inc's Latuda Tabl...
Novartis signs deal with Gan & Lee as US government seeks to slash insulin cost Medical Dialogues Bureau30 Dec 2018 3:50 AM GMTZURICH: Swiss drugmaker Novartis aims to become a big player in supplying insulin to swelling numbers of diabetics, signing a deal with China's Gan...
