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Shilpa Medicare gets USFDA nod for arthritis drug

Shilpa Medicare has received United States Food and Drug Administration (USFDA) s tentative approval for its abbreviated new drug application (ANDA), apremilast tablets, 10 mg, 20 mg, and 30 mg.
The ANDA was filed as First to File submission on NCE -1 date to seek eligibility for 180 days exclusivity.
Apremilast tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene, used in the treatment of psoriatic arthritis as recommended in the label approved by FDA.
According to IQVIA MAT Q2 2020 data, the US market for apremilast tablets, 10 mg, 20 mg, and 30 mg is approximately US $2.4 billion.
Shilpa Medicare is a global brand in manufacturing and supplying of affordable API and formulation globally in different regulated markets. ....

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Zydus Cadila receives USFDA approval for Nortriptyline Hydrochloride Capsules

This medication is used to treat mental/mood problems such as depression.
It may help improve mood
and feelings of well-being, relieve anxiety and tension, and increase one s energy level. The drug will
be manufactured at the group s formulation manufacturing facility at the SEZ, Ahmedabad.
The group now has 313 approvals and has so far filed over 400 ANDAs since the commencement of
the filing process in FY 2003-04.
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Granules India receives USFDA approval for Acetaminophen, Aspirin and Caffeine Tablets

Granules India announced today that the US Food & Drug Administration (US FDA) has approved its
Abbreviated New Drug Application (ANDA) for Acetaminophen, Aspirin and Caffeine Tablets USP, 250
mg/250 mg/65 mg (OTC).
It is bioequivalent to the reference listed drug product (RLD), Excedrin Migraine
Tablets, 250 mg/250 mg/65 mg, of GlaxoSmithKline Consumer Healthcare. The product would be
manufactured at the company s Hyderabad facility and is expected to be launched shortly.
Acetaminophen, Aspirin and Caffeine Tablets are indicated for the treatment of migraine.
Granules now has a total of 38 ANDA approvals from US FDA (37 Final approvals and 1 tentative
approval)
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Unichem Labs spurts on USFDA nod for psoriasis drug

Unichem Laboratories surged 5.71% to Rs 323.05 after the company received United States Food and Drug Administration (USFDA) approval for apremilast tablets, 10 mg, 20 mg and 30 mg.
The drug is a generic version of Amgen s Otezla (apremilast) tablets, 10 mg, 20 mg, and 30 mg.
The drug is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
The scrip extended gains for third day. The stock has added 6.67% in three sessions from its recent closing low of Rs 302.85 recorded on 16 February 2021.
In the past three months, the stock has added 36.73% while the benchmark Sensex has added 17.55% during the same period. ....

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Indices hover near day's low; breadth negative

The equity barometers were trading near the day s low in afternoon trade. The Nifty was hovering below 15,050 level. Rising COVID-19 case and negative global cues impacted domestic sentiment. PSU banks and auto shares corrected sharply.
At 13:20 IST, the barometer index, the S&P BSE Sensex, dropped 216.25 points or 0.42% at 51,108.44. The Nifty 50 index lost 74.30 points or 0.49% at 15,044.65.
Selling was broad based. The S&P BSE Mid-Cap index slipped 0.85%. The S&P BSE Small-Cap index fell 0.11%.
Sellers outnumbered buyers. On the BSE, 1,400 shares rose and 1,444 shares fell. A total of 161 shares were unchanged. In Nifty 50 index, 12 stocks advanced while 38 stocks declined.
Foreign portfolio investors (FPIs) bought shares worth Rs 903.07 crore, while domestic institutional investors (DIIs), were net sellers to the tune of Rs 1,217.34 crore in the Indian equity market on 18 February 2021, provisional data showed. ....

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