• Regulatory NewsRegulatory News

    Generic drug approvals continued to fall in 2021

    The US Food and Drug Administration (FDA) approved or tentatively approved 776 Abbreviated New Drug Applications (ANDAs) for generic drugs in 2021, continuing a steady decline in generic approvals in recent years.   In calendar year 2020 , FDA approved or tentatively approved 948 ANDAs for generic drugs, which was down from 1,014 in 2019 . The latest figures are part of the FDA’s Office of Generic Drugs (OGD) 2021 Annual Report .   But the agency approved 93 “fi...
  • Regulatory NewsRegulatory News

    FDA shows jump in competitive generic approvals

    The US Food and Drug Administration (FDA) approved a steadily increasing number of competitive generic therapy (CGT) abbreviated new drug applications (ANDAs) in FY 2021 while the number of priority generic approvals leveled off, according to agency’s quarterly data on reviews and approvals of priority and competitive generics.   FDA approved 29 priority ANDAs in FY 2021, one more than the 28 approved in  FY 2020 . There was an increase of about 8% in the number of ...
  • FTC Raises Concerns About Quality, Authenticity of Pet Medications

    The Federal Trade Commission (FTC) has released the draft agenda for an upcoming meeting that could shake up the veterinary pharmaceutical sector. The meeting, "Competition & Consumer Protection Issues in the Pet Medications Industry," was first announced in June 2012, and was called in response to FTC's perception that consumer-focused veterinary medications were subject to anti-competitive pricing and access issues. "American consumers spend a tremendous amount ...
  • US Agency Launches Investigation Into Veterinary Pharmaceutical Industry

    The US Federal Trade Commission (FTC) is announcing an investigation into competitive issues in the veterinary pharmaceuticals market after concerns were raised to it regarding the pricing of medications and possible anti-competitive issues. "American consumers spend a tremendous amount of money on medications for their pets every year," FTC Chairman Jon Leibowitz explained in a statement. "High prices on these medications mean that consumers have less money for necessit...
  • California Supreme Court Looks to Take Up 'Pay for Delay' Case

    The California Supreme Court is set to review a case on so-called 'pay for delay' settlements that see pharmaceutical manufacturers pay generic manufacturers to secure additional months of market exclusivity for their products. The court will review a decade-old class-action lawsuit against Bayer over its pay for delay settlement to Barr Laboratories. Barr was reportedly planning to sell a generic version of Bayer's antibiotic, Cipro (ciprofloxacin). The lawsuit alleges...