Alembic Pharma`s Generic Bosentan Receives Approval in U.S
Alembic Pharmaceuticals Limited (Alembic) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bosentan Tablets, 62.5 mg and 125 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tracleer Tablets, 62.5 mg and 125 mg, of Actelion Pharmaceuticals Limited. Bosentan Tablets indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1 ).
Mylan's Generic Bosentan Receives Approval in U.S
Cipla Pharma's Generic Bosentan Receives Approval In Us
The U.S. FDA compiles a list of off-patent drugs without an approved generic to encourage the development of copycats. Now, the Chinese authorities are rolling out a similar initiative, only with some extra incentives.
Share price of Lupin rose 1.3 percent intraday Thursday after company in alliance with Natco Pharma received approval for Bosentan tablets, 62.5 mg and 125 mg, from the United States Food and Drug Administration (USFDA) to market a generic version of Actelion Pharmaceuticals.
Drug firm Lupin, in alliance with Natco Pharma, has received approval from the US health regulator to market generic Bosentan tablets used for treatment of pulmonary arterial hypertension, the Mumbai-based company said Tuesday.
FDA Confirms Paragraph IV Patent Challenge of Tracleer 209279 (Bosentan) for Oral Suspension 32 mg
J&J unit to pay $360 million to U.S. to resolve charity kickback probe
The FDA has followed through on plans to identify pharma companies they believe have tried to block generic copies of their brands, for example by making it hard to acquire medicines for bioequivalence studies.