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Generics

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Teva Gets EU Backing For OTC Desloratadine

Teva subsidiary Ratiopharm has secured EMA backing for the EU-wide switch of allergy drug desloratadine.

Generic Drugs OTC Drugs

Awards Offers Two Weeks Of Online Networking

From 20 October, a free online platform will allow registrants attending the digital Global Generics & Biosimilars Awards 2020 to participate in two weeks of dedicated networking activities ahead of the ceremony on 3 November.

Generic Drugs Biosimilars

Mylan Obtains CHMP Backing For Revlimid Generic In Two Indications

Mylan is taking aim at a lucrative oral solid formulation in Europe, with the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending approval for the company’s generic version of Revlimid (lenalidomide) capsules.

Generic Drugs Regulation

Rivals Challenge Nintedanib In India

Glenmark and Sun Pharma introduce nintedanib generics in India at a fraction of the innovator product’s price, vying for a share of the IPF market where pirfenidone currently holds sway.

Launches Generic Drugs

Australia Changes Patent Notification Requirements

Australia’s Therapeutic Goods Administration has set out proposals for a change to early-notification requirements for generic and biosimilar sponsors.

Regulation Intellectual Property

AAM Urges FDA To Reassess Nitrosamines

The AAM has published a position paper on nitrosamines that urges the FDA to revisit and reassess its safety limits for nitrosamines in pharmaceuticals, while also proposing a “science-driven” risk-based approach to evaluate drugs for the potential presence of nitrosamines.

Generic Drugs Regulation
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