India's generic firm Glenmark has stopped selling codeine sulfate pills used to manage pain, following US FDA's directive to stop marketing the tablets that have not received FDA approval.
Rising demand in US market spurs growth; Chinese pharma to grow 20+ % yearly, says IMS Health report
US FDA seized drug products manufactured at Caraco’s facilities in Detroit in June
Indian generic firm Aurobindo Pharma received tentative approvals for its abbreviated new drug application (ANDA) under Para IV certification for atomexetine hydrochloride 10 mg, 18 mg, 25mg, 40 mg, 60 mg, 80 mg and 100 mg strengths with first to file status from US FDA.
India's Sun Pharma is planning to make generic version of the painkiller drug tramadol extended release for US market, raising possibility of encountering patent infringement lawsuit from Ryzolt's developer Lobopharm and its marketing partner Purdue.
Wockhardt has received tentative approval for generic tamsulosin hydrochloride from the United States Food & Drug Administration (US FDA).
India's Dr. Reddy's Laboratories Ltd has recalled citalopram,fexofenadine, pravastatin and risperidone tablets in certain strengths from US market, following concerns of on the size and proportion of these pills which are found to be above the stipulated standard size norms.
Stelara (ustekinumab) marketed by Janssen-Ortho Inc has been approved for the treatment of moderate to severe plaque psoriasis in adults by USFDA.
Dr Reddy's is the first to launch nateglinide generic, but likely to share exclusivity with Teva, Par.
Paramivir is administered directly as intravenous (IV) injection, unlike oseltamivir pill and zanamivir inhaler