Daily Chemical News Recommendation ( Sept. 28 2018)

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 >> Glenmark receives ANDA approval for steroidal drug from US FDA

Glenmark Pharmaceuticals Inc., USA has been granted final approval by the US FDA for Estradiol Vaginal Inserts USP, 10 mcg, the generic version of Vagifem1, 10 mcg, of Novo Nordisk Inc.

According to IQVIA sales data for the 12-month period ending July 2018, the Novo Nordisk product achieved annual sales of approximately $286.3-mn.

Glenmark’s current portfolio consists of 139 products authorized for distribution in the US market and 61 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.[More]

>>Sun Pharma and SPARC announce US FDA nod for glaucoma drug

Sun Pharmaceutical Industries Ltd. and Sun Pharma Advanced Research Company Ltd. (SPARC) have announced USFDA approval for the New Drug Application (NDA) of Xelpros (latanoprost ophthalmic emulsion) 0.005% for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. This approval is from Sun Pharma’s Halol (Gujarat) facility. Sun Pharma in-licensed Xelpros from SPARC in June 2015 and this approval will trigger a milestone payment to SPARC. SPARC is also eligible for milestone payments and royalties on commercialisation of Xelpros in the US.  [More]