US FDA gives final approval to Glenmark Pharma’s Sodium Phenylbutyrate tablets
The tablets will be distributed in the US by Glenmark Pharma Inc., USA
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Browsing Tag
US FDA approval
US FDA gives final approval for Mesalamine extended-release capsules
Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
US FDA gives final approval to Zydus’s Acetaminophen injection
Acetaminophen injection is indicated to relieve mild-to-moderate pain, and to reduce fever
US FDA gives final approval to Alembic Pharma’s Paclitaxel injection
This is the first product approval for oncology injection from the company's F-2 Facility (oncology injectable) which recently…
Johnson & Johnson’s blood cancer therapy gets US FDA approval
J&J's teclistamab, branded as Tecvayli, is approved for treating adults with multiple myeloma that is hard to treat, or has…
US FDA grants final approval to Zydus’s Micafungin for injection
Micafungin for injection is indicated to treat variety of fungal infections
US FDA authorises Novavax’s COVID vaccine as booster for adults
The regulator's decision is in addition to the earlier clearance for the vaccine as a primary two-shot regimen for those aged 12…
US FDA grants tentative approval to Zydus’s Amantadine extended-release capsules
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ
Zydus receives final approval from the US FDA for Sildenafil for oral suspension
Sildenafil for oral suspension is used to treat high blood pressure in the lungs (pulmonary hypertension)
Zydus receives final US FDA approval for Brivaracetam tablets
Brivaracetam is indicated for the treatment of partial-onset seizures in patients four years of age and older