Glenmark gets US FDA nod for nasal spray to treat seasonal allergic rhinitis
With this NDA approval, the company looks forward to bringing this new medicine to physicians and their patients for the treatment…
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Browsing Tag
US FDA approval
Alembic Pharmaceuticals receives US FDA tentative approval for Dronedarone tablets
Dronedarone is indicated to reduce the risk of hospitalisation for atrial fibrillation in patients in sinus rhythm with a history…
Alembic Pharmaceuticals receives US FDA tentative approval for Vortioxetine tablets
The tablets are indicated for the treatment of Major Depressive Disorder (MDD)
Alembic Pharmaceuticals receives USFDA final approval for Entacapone tablets
The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Comtan tablets, 200 mg, of Orion…
Alembic Pharmaceuticals receives US FDA approval for Doxycycline Hyclate delayed-release tablets
The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Doryx tablets, 75 mg, 100 mg, 150 mg…
Zydus Cadila receives tentative approval from US FDA for Pimavanserin capsules
Pimavanserin is an atypical antipsychotic and is indicated for the treatment of hallucinations and delusions associated with…
Granules Pharmaceuticals receives ANDA approval for Amphetamine mixed salts from US FDA
The product is bioequivalent to the Reference Listed Drug (RLD) product Adderall of Teva Women’s Health Inc, and would be…
Amphastar Pharma receives tentative approval from US FDA for Vasopressin injection
The FDA determined that Amphastar's Vasopressin is bioequivalent and therapeutically equivalent to Par Sterile Products LLC's…
Lupin gets tentative US FDA nod for generic tablets to treat high BP
These are generic equivalent of Edarbi tablets, 40 mg and 80 mg of Arbor Pharmaceuticals, LW
US FDA authorises first oral antiviral to treat COVID
The antiviral, Paxlovid, is not authorised for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of…