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Home » Topics » Pharmaceuticals » Postmarket Safety

Postmarket Safety
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Beleaguered Wockhardt’s Regulatory Hurdles Increase With Second FDA Import Ban

November 27, 2013
The FDA Tuesday hit Wockhardt with a second “import alert,” banning drug products from its Chikalthana plant in western India — the latest in a spate of regulatory actions taken against the struggling drugmaker. Read More

Duchesnay Flagged for Omitting Risks of Morning Sickness Drug

November 27, 2013
Shortly after Duchesnay received FDA approval for its morning sickness drug Diclegis, the agency says the Canadian drugmaker sent a letter to customers touting the drug’s benefits but none of its risks. Read More

FDA Relaxing Restrictions on GSK’s Controversial Diabetes Drug Avandia

November 27, 2013
Three years after placing heavy restrictions on GlaxoSmithKline’s type 2 diabetes drug Avandia, the FDA said Nov. 25 it is relaxing those restrictions in line with its advisers’ recommendations. Read More

FDA Advisors to Mull New Methods of Communicating REMS Risk Information

November 26, 2013
The FDA is seeking input on the effectiveness of risk evaluation and mitigation strategy (REMS) programs as it weighs whether new methods of communicating drug risks in REMS are needed. Read More

FDA Probe Into Plan B Effectiveness May Prompt Label Changes

November 26, 2013
The FDA is investigating reports that emergency contraceptives such as Teva’s Plan B One-Step lose effectiveness in women over 165 lbs. and don’t work at all for women over 175 lbs. Based on its review, labeling changes for the drugs may be forthcoming. Read More

FDA Relaxes Avandia Restrictions

November 25, 2013
Three years after placing heavy restrictions on GlaxoSmithKline’s type 2 diabetes drug Avandia, the FDA said Monday it is relaxing those restrictions in line with its advisers’ recommendations. Read More

Amgen Gets Untitled Letter as FDA Steps Up Advertising Enforcement

November 25, 2013
Amgen is the latest drugmaker caught up in the FDA’s recent flurry of enforcement letters for false or misleading promotional materials. An ad developed by the company for its anemia drug Aranesp omitted risks and inflated efficacy claims, the agency says. Read More
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EMA OKs Continued EU Availability of Ariad’s Iclusig

November 22, 2013
EU regulators on Friday assured Ariad that its leukemia drug and sole product Iclusig can continue to be sold throughout Europe for its approved indications. Read More

Pharmaceutical Track-and-Trace Legislation Passes Senate, Advances to President Obama

November 22, 2013
Drugmakers have 13 months to revamp how they track drugs after the Senate voted Nov. 18 to send to President Barack Obama’s desk a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More

Senate Passes Prescription Drug Track-and-Trace Legislation

November 22, 2013
Drugmakers have 13 months to revamp how they track drugs after the Senate voted Nov. 18 to send to President Barack Obama’s desk a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More

Four EU Countries Warned for Feet-Dragging on Falsified Medicines Directive

November 22, 2013
The European Commission (EC) is threatening to take legal action against Italy, Poland, Slovenia and Finland for failing to implement the Falsified Medicines Directive, an EU-wide anti-counterfeit initiative that has been in effect since Jan. 2, 2013. Read More

Duchesnay Flagged for Omitting Risks of Morning Sickness Drug

November 22, 2013
Shortly after Duchesnay received FDA approval for its morning sickness drug Diclegis, the agency says the Canadian drugmaker sent a letter to customers touting the drug’s benefits but none of its risks. Read More
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