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Mylan Pharmaceuticals Inc.

https://www.mylan.com

Latest From Mylan Pharmaceuticals Inc.

‘Skinny Label’ Litigation: Generic Firms Rethinking Strategy, May Pursue Legislation

Generic manufacturers are being cautious on label carve-outs to avoid claims of induced infringement. Bright line rules are necessary, attorney says, and if GSK v. Teva decision is not reversed, legislation will be needed to preserve skinny label. Insurers also face potential liability for placement of skinny-label generics on formularies.

Generic Drugs Intellectual Property

US FDA GMP Warnings To OTC Firms In China, South Korea

Cosmo Bio's response to remote records request shows the South Korea company was marketing an unapproved OTC acne treatment without adequate release or stability testing. In China, Hubei Kangzheng was manufacturing an ophthalmic in a Grade D area without appropriate microbial controls.

Warning Letters OTC Drugs

The Quality Lowdown: More Inspection Delays, More Findings On Sterility And Investigations

US FDA hits firms in New Jersey, South Korea and China with warning letters. Meanwhile, Catalent and several outsourcing facilities work on Form 483 inspection findings as Mylan, Viona and Lohxa announce drug recalls.

Manufacturing Quality

US FDA Drafts Guidance Advising Holistic Approach To Further Control Particulates

Guidance aligns with USP Chapters <790> and <1790>; encourages risk-based approach to identifying and correcting particulate contamination of sterile injectables to build on recent successes in reducing particulate-driven recalls.

Manufacturing Quality
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