Alembic’s generic Vibramycin gets FDA OK
The Food and Drug Administration has approved Alembic Pharmaceuticals’ generic Vibramycin (doxycycline hyclate). The drug is indicated to treat various bacterial infections, including those caused by gram-negative and gram-positive microorganisms.
It also is indicated to prevent malaria due to Plasmodium falciparum in short-term travelers to areas with certain resistant strains. It also can be used as adjunctive therapy in severe acne and in acute intestinal amebiasis.
Alembic’s generic Vibramycin will be available in 50- and 100-mg dosage strength tablets. The drug’s market size was roughly $80 million for the 12 months ended December 2017, according to IQVIA data.
The approval of its generic Vibramycin was the second in a week for Alembic, which received approval for its generic Wellbutrin on June 11.
It also is indicated to prevent malaria due to Plasmodium falciparum in short-term travelers to areas with certain resistant strains. It also can be used as adjunctive therapy in severe acne and in acute intestinal amebiasis.
Alembic’s generic Vibramycin will be available in 50- and 100-mg dosage strength tablets. The drug’s market size was roughly $80 million for the 12 months ended December 2017, according to IQVIA data.
The approval of its generic Vibramycin was the second in a week for Alembic, which received approval for its generic Wellbutrin on June 11.