Approvals

  • FDA Approves Lupin’s Generic Diclofenac Capsules

    Lupin has announced that it has received tentative approval from the FDA to begin marketing a generic version of Diclofenac capsules. The drug is used...

  • FDA Approves Lupin’s Generic Nuvigil Tablets

    Lupin, which is based out of India, has announced that the FDA has approved its application to produce a generic version of Nuvigil Tablets in...

  • FDA Approves Natco’s Generic Budesonide Capsules

    Natco Pharma has announced receiving FDA approval to produce a generic version of budesonide capsules. Budesonide capsules are used to treat Crohn’s disease. The drug...

  • Dr. Reddy’s Launches Generic Osteoporosis Drug

    Dr. Reddy’s has announced the launch of a generic osteoporosis drug in the US market. The drug, raloxifene hydrochloride, will come in tablet form in...

  • EMA Recommends New Generics and Biosimilars For Approval

    The European Medicines Agency’s Committee for Medicinal Products for Human Use has announced that it has recommended nine drugs for approval. After the regulatory body’s...

  • FDA Approves Teva’s Generic Tribenzor

    Teva Pharmaceutical Industries has announced receiving approval to produce generic Tribenzor tablets from the FDA. The drug combines an angiotension II receptor blocker, a calcium...

  • FDA Approves Jubilant Generic

    Jubilant Life Sciences has announced receiving FDA approval to produce a generic version of IPR Pharmaceuticals’ Crestor. The generic drugs will be named Rosuvastatin Calcium...

  • FDA publishes GDUFA reauthorization draft agreement

    It has been announced that the US Food and Drug Administration (FDA) has reached an in-principle agreement on the details that will be included in...

  • Sun Pharma Announces Launch of Hypertension Generics

    Sun Pharma has announced the launch of generic versions of several Daiichi Sankyo hypertension products. Sun Pharma will be producing generic versions of Benicar, Benicar...

  • FDA Approves Second Beximco Pharma Generic

    Beximco Pharmaceuticals has announced receiving a second approval from the FDA for sotalol hydrochloride. The drug is the generic version of Betapace, a cardiovascular drug,...