Alembic receives FDA nod for 2 generics
The FDA has approved Alembic's generic Albenza and generic Invega. Alembic has received The Food and Drug Administration’s clearance for two generics. The company obtained approvel for albendazole tablets, 200 mg, which is the generic of Impax's Albenza.
Alembic Pharma gets USFDA nod for generic drug used to treat schizophrenia
Paliperidone extended-release tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg have an estimated market size of $48 million for 12 months ended June 2024.
Alembic Pharma gets US FDA approval for paliperidone ER tablets
Alembic Pharma gets US FDA approval for paliperidone ER tablets: Our Bureau, Bengaluru Monday, September 30, 2024, 11:30 Hrs [IST] Alembic Pharmaceuticals has received final appro
Alembic Pharma secures FDA approval for Schizophrenia treatment, stocks in red
Alembic Pharmaceuticals receives FDA approval for Paliperidone Tablets, trading at ₹1,179.95 on NSE, expanding its global presence.
Alembic Pharma receives USFDA approval for schizophrenia drug Paliperidone Extended Release
Mumbai: Alembic Pharmaceuticals Limited today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application
Alembic Pharma Gets USFDA Nod for Generic Schizophrenia Drug
Alembic Pharmaceuticals receives USFDA approval for its generic version of Paliperidone extended-release tablets, indicated for treating schizophrenia. The drug is therapeutically equivalent to Invega.
Bristol Myers gets USFDA nod for new type of schizophrenia drug
Schizophrenia causes persistent delusions and hallucinations and significantly impairs the way patients perceive reality.
Alembic Pharma gets USFDA nod for Paliperidone extended-release Tablets
Alembic Pharmaceuticals has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paliperidone extended-release tablets.
clinicaltrialsarena2d
A schizophrenia win for BMS’ Cobenfy, but challenges lie ahead
On 26 September 2024, Bristol Myers Squibb (BMS) announced that the US Foof and Drug Administration approved Cobenfy ...
ndtvprofit7d
Alembic Pharma Gets USFDA Approval For Generic Paliperidone Tablets
The approved strengths are 1.5 mg, 3 mg, 6 mg, and 9 mg, and the product is therapeutically equivalent to Janssen's Invega.
Medscape3d
Onset of Efficacy and Tolerability Following the Initiation Dosing of Long-acting Paliperidone Palmitate
With respect to tolerability concerns with the recommended paliperidone palmitate initiation dosing, this study did not reveal unexpected adverse events or high rates of specific adverse events in ...
JD Supra10d
Supreme Court of Canada to hear method of medical treatment appeal
On September 19, 2024, the Supreme Court of Canada granted Pharmascience leave to appeal a Federal Court of Appeal decision ...
News Medical3d
Invega Hafyera
INVEGA HAFYERA contains the active ingredient paliperidone palmitate. INVEGA HAFYERA is used to treat schizophrenia in adults (18 years of age and older). For more information, see Section 1.
Medscape13y
Paliperidone ER and Oral Risperidone in Patients with Schizophrenia
Background: To compare the efficacy and tolerability of paliperidone extended-release (ER) with risperidone immediate-release using propensity score methodology. Methods: Six double-blind ...
Monthly Prescribing Reference2y
Invega Trinza
Paliperidone (as palmitate) 273mg, 410mg, 546mg, 819mg; ext-rel susp for IM inj. Schizophrenia after adequately treated with Invega Sustenna (1-month paliperidone palmitate ext-rel inj susp ...