Alembic Pharmaceuticals Ltd says it has received tentative approval from the US Food and Drug Administration (USFDA) for its generic version of binimetinib tablets. In a regulatory filing, the company states the tentative approval applies to its Abbreviated New Drug Application (ANDA) for binimetinib tablets in the 45 mg strength. One outlet reports that, based on USFDA’s paragraph IV certifications list, Alembic is the sole first applicant that has filed an ANDA for the 45 mg product. The company adds that, if the ANDA receives final approval, it may be eligible for 180 days of generic marketing exclusivity in the US. The reports also note that Alembic had previously received tentative approval for binimetinib tablets in the 15 mg strength. Binimetinib is used in combination with encorafenib for treatment of certain cancers, including unresectable or metastatic melanoma with resistance to specific targeted therapies and metastatic non-small cell lung cancer (NSCLC) with resistance to specific targeted therapies. Alembic cites IQVIA data estimating a market size of about USD 259 million for the 12 months ending March 2026.
Alembic Pharma receives tentative USFDA approval for generic binimetinib 45 mg tablets
Alembic Pharmaceuticals Ltd says it has received tentative approval from the US Food and Drug Administration (USFDA) for its generic version of binimetinib tablets. In a regulatory filing, the company...
- Alembic Pharmaceuticals receives USFDA tentative approval for a generic binimetinib tablet ANDA.
- The tentative approval is for binimetinib tablets, 45 mg strength.
- The company says it is the sole first applicant for the 45 mg ANDA based on USFDA paragraph IV certifications.
- Alembic says final approval could make it eligible for 180 days of generic marketing exclusivity in the US.
- Binimetinib is used with encorafenib for specified melanoma and NSCLC indications.
USFDA’s tentative approval is for the ANDA of Binimetinib tablets of strength 45 mg
2 months agoNew Delhi: Alembic Pharmaceuticals Ltd on Friday said it has received tentative approval from the US health regulator for its generic version of cancer treatment drug Binimetinib tablets.The tentative approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of Binimetinib tablets of strength 45 mg, Alembic Pharmaceuticals said in a regulatory filing.Based on USFDA's paragraph IV certifications list, Alembic is the sole first applicant to have filed its ANDA for Binimetinib Tablets, 45mg and upon final approval of this ANDA by the USFDA, the company may be eligible for 180 days of generic marketing exclusivity in the US, the company said.Read More: Maharashtra FDA bars hospitals from forcing patients to buy medicines in-houseAlembic had previously received tentative approval for Binimetinib Tablets, 15mg, it added.Binimetinib in combination with encorafenib is used for the treatment of patients with unresectable or metastatic melanoma with resistance to specific targeted therapies in cancer.It is also indicated, in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with resistance to specific targeted therapies.Read More: India raises price cap on cancer drugs to tackle shortageCiting IQVIA data, Alembic said Binimetinib tablets have an estimated market size of USD 259 million for 12 months ending March 2026.
2 months ago
Norway’s King Harald V dies at 89; his son becomes King Haakon VIII
Norway’s King Harald V dies at 89, and his son becomes King Haakon VIII. Multiple outlets report that Harald dies in Osl...
Dolly Parton offered to try experimental cancer drugs, sister says
Singer Dolly Parton’s younger sister, Stella Parton, says Parton offered to allow her medical team to try experimental d...
Rescuers search after Nepal–Tibet flash floods as dozens of Britons are reported missing
Rescue teams are searching in Nepal and along the border with Tibet after flash floods caused by a glacier collapse deva...