New Delhi: Drug firm Strides Shasun said it has received approval from the US health regulator for anti-inflammatory Ibuprofen tablets and for Milnacipran Hydrochloride tablets used for treating pain due to a certain condition.
Company’s arm Strides Pharma Global has received final approval for Ibuprofen tablets USP, 200 mg from the United States Food & Drug Administration (USFDA), Strides Shasun said in a filing to BSE.
The tablets will be manufactured at the company’s oral dosage facility at Puducherry and will be marketed by Strides Pharma Inc in the US, Strides Shasun said.
“The approval further strengthens Strides Ibuprofen franchise for the US markets that now comprises 7 approved products addressing a combined Rx and OTC opportunity of USD 900 million as per IMS and IRI data,” it added.
Ibuprofen is used to relieve a headache, dental pain, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to common cold or flu, the company said.
Strides Pharma Global has also received tentative approval from USFDA for its Para IV filing of Milnacipran Hydrochloride tablets in the strengths of 12.5 mg, 25 mg, 50 mg, and 100 mg, Strides Shasun said.
The product is a generic version of Allergan Sales LLC’s Savella tablets, it added.
“As per IQVIA MAT data, the US market for Milnacipran Hydrochloride tablets is approximately USD 145 million,” Strides Shasun said.
The product will be manufactured at the company’s oral dosage facility at Puducherry and marketed by Strides Pharma Inc in the US market, it added.
Milnacipran Hydrochloride tablet is used to treat pain caused by a condition called fibromyalgia that affects muscles, tendons, ligaments, and supporting tissues, Strides Shasun said.
The company has 75 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 51 have been approved as of date and 24 are pending approval, it added.