A study on the public health and socioeconomic impact of substandard and falsified medical products, showed that 10% of ...

A generic product cannot enter the market until the originator product’s IP has expired, but the development process can take ...

Lupin Limited today announced that it has received tentative approval from the United States Food and Drug Administration for ...

As the craze of earnings season draws to a close, here’s a look back at some of the most exciting (and some less so) results ...

Mumbai: Global pharma major Lupin Limited has announced that it has received tentative approval from the United States Food ...

Lupin has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Amifampridine Tablets, 10 mg. This product would be ...

Therapeutic equivalence Two products are considered to be therapeutically equivalent when they are pharmaceutically equivalent and bioequivalent (i.e. have the same absorption and bioavailability of ...

Pharmaceutical equivalent is defined in section C.08.001.1 of the FDR: means a new drug that, in comparison with another drug, contains identical amounts of the ...

FDA took issue with the promotional communication presented in an exhibit booth panel (“panel”) [2] for Hemady ®, a drug indicated in combination with other anti-myeloma products for the treatment of ...