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Biosimilars regulations unlikely to unfold soon
As soon as members of Congress took their seats last month, the new Republican majority announced it would make good on its pledge to repeal the Patient Protection and Affordable Care Act. The effort largely is symbolic and unlikely to succeed, so at least one portion of the healthcare-reform law will likely remain in effect, namely the abbreviated approval pathway for follow-on biologics, also known as the Biologics Price Competition and Innovation Act.
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Dr. Reddy's gets OK to market generic allergy drug
HYDERABAD, India — A federal court has lifted an injunction that had prevented drug maker Dr. Reddy’s Labs from marketing a generic version of an allergy drug.
Dr. Reddy’s said the U.S. District Court of New Jersey had filed a stipulation and order lifting the earlier injunction against the drug maker regarding the selling of a version of fexofenadine hydrochloride and pseudoephedrine hydrochloride tablets in the 180-mg/240-mg strength. The drug is a generic version of Sanofi-Aventis’ and Albany Molecular Research’s Allegra-D 24.