Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 22

Results For "approvaL"

2469 News Found

Alembic Pharmaceuticals receives USFDA final approval for Lamotrigine Extended-Release Tablets
Drug Approval | October 03, 2024

Alembic Pharmaceuticals receives USFDA final approval for Lamotrigine Extended-Release Tablets

Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures


Aurobindo Pharma receives USFDA approval for Cephalexin Tablets
Drug Approval | October 02, 2024

Aurobindo Pharma receives USFDA approval for Cephalexin Tablets

The product is expected to be launched in Q3FY25


Zydus receives tentative approval from USFDA for Enzalutamide Tablets
Drug Approval | October 02, 2024

Zydus receives tentative approval from USFDA for Enzalutamide Tablets

Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad


Zydus receives USFDA final approval for Enzalutamide Capsules, 40 mg
Drug Approval | September 28, 2024

Zydus receives USFDA final approval for Enzalutamide Capsules, 40 mg

Enzalutamide Capsules will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad


Alembic receives USFDA final approval for Paliperidone ER tablets
News | September 27, 2024

Alembic receives USFDA final approval for Paliperidone ER tablets

Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for treatment of schizophrenia


Asahi Kasei Pharma obtains approval to manufacture and sell Cresemba Capsule 40 mg as additional formulation in Japan
Drug Approval | September 26, 2024

Asahi Kasei Pharma obtains approval to manufacture and sell Cresemba Capsule 40 mg as additional formulation in Japan

The product is an additional formulation of Cresemba Capsule 100 mg and Cresemba Intravenous Infusion 200 mg


Bavarian Nordic receives EMA approval of mpox vaccine for adolescents
Drug Approval | September 23, 2024

Bavarian Nordic receives EMA approval of mpox vaccine for adolescents

MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMA


Fasenra recommended for approval in the EU by CHMP for treatment of EGPA
Drug Approval | September 23, 2024

Fasenra recommended for approval in the EU by CHMP for treatment of EGPA

New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids


Roche receives USFDA approval for Ocrevus Zunovo for treatment of progressive multiple sclerosis
Drug Approval | September 19, 2024

Roche receives USFDA approval for Ocrevus Zunovo for treatment of progressive multiple sclerosis

This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally


Lupin receives USFDA approval for Bumetanide Injection
Drug Approval | September 19, 2024

Lupin receives USFDA approval for Bumetanide Injection

Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.