Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs

18 June 2019 - The U.S. FDA is committed to helping facilitate American patients’ access to lower-cost generic medicines by ...

Read more →

FDA's strengthened global inspection program helps ensure generic drug safety

17 May 2019 - Consumers must have confidence in the safety and quality of generic medicines.  ...

Read more →

Safety, efficacy, and quality remain top priorities as we continue our work to expand access to cost-saving generic drugs for the American public

13 May 2019 - Millions of Americans have difficulty paying for their prescription medications. ...

Read more →

Intellipharmaceutics announces FDA approval for generic Pristiq

10 May 2019 - Intellipharmaceutics announced today that it has received approval from the U.S. FDA for the Company's abbreviated new ...

Read more →

Teva and other generic drug makers inflated prices up to 1,000%, State prosecutors say

11 May 2019 - According to a new lawsuit, generic medications including oral antibiotics, blood thinners, cancer drugs, contraceptives and HIV ...

Read more →

Allegations of widespread fraud raise questions about the safety of generic drugs made overseas

10 May 2019 - It is something we've all heard before: generic drugs are the same as brand-name drugs. They ...

Read more →

They were supposed to talk about the patent system driving up drug prices. But most lawmakers got distracted by small tweaks.

7 May 2019 - If there was any hope that Congress might overhaul the way this country doles out the ...

Read more →

FDA approves first generic naloxone nasal spray to treat opioid overdose

19 April 2019 - Agency is also taking new steps to support development of over-the-counter and additional generics of naloxone to ...

Read more →

Supporting greater availability of lower cost generic drugs for Canadians

4 April 2019 - Canadians want improved access to a wider range of safe and affordable medications.  ...

Read more →

FDA approves a new generic valsartan

12 March 2019 - Today, the U.S. FDA approved a new generic of Diovan (valsartan).  ...

Read more →

“Repurposing” off-patent drugs offers big hopes of new treatments

28 February 2019 - Towards the end of 2014 a 66-year-old British man named Alistair had a seizure. A scan ...

Read more →

Statement from FDA Commissioner and Director of FDA’s Center for Drug Evaluation and Research on the FDA’s continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad

22 February 2019 - At the FDA, protecting patient and consumer health is our highest priority. Assessing and mitigating risks ...

Read more →

Indivior launches generic version of its Suboxone opioid drug

20 February 2019 - British drugmaker Indivior said on Wednesday it had launched a copycat version of its blockbuster opioid ...

Read more →

Statement from FDA Commissioner on new policy to improve access and foster price competition for drugs that face inadequate generic competition

15 February 2019 - In too many cases, branded drugs that are no longer protected by patents or other exclusivities ...

Read more →

Mylan launches Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder), at a list price 70% less than the brand

12 February 2019 - Unique pricing of Wixela Inhub immediately benefits patients and reduces overall cost to the U.S. health care ...

Read more →